FDA 510(k) Applications for Medical Device Product Code "JHI"
(Radioimmunoassay, Human Chorionic Gonadotropin)

FDA 510(k) Number Applicant Device Name Decision Date
K953486 3C DIAGNOSTICS, INC. MIT ONE STEP PREGNANCY TEST 12/21/1995
K880070 ABBOTT LABORATORIES ABBOTT IMX HCG 03/24/1988
K820271 ABBOTT LABORATORIES ABBOTT LABORATORIES B-HCG EIA 03/11/1982
K863032 ABBOTT LABORATORIES ABBOTT TESTPACK (TM) HCG SERUM 09/15/1986
K870739 ABBOTT LABORATORIES ABBOTT TESTPACK HCG COMBO 05/20/1987
K853539 ABBOTT LABORATORIES ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT 09/25/1985
K965116 ABBOTT LABORATORIES ABBOTT TESTPACK PLUS HCG COMBO WITH OBC 02/20/1997
K894408 ABBOTT LABORATORIES ABBOTT TESTPACK PLUS HCG URINE 09/05/1989
K903219 ABBOTT LABORATORIES ABBOTT TESTPACK PLUS TM HCG-COMBO 09/25/1990
K935673 ABBOTT LABORATORIES AXSYM TOTAL B-HCG 06/21/1994
K852183 ABBOTT LABORATORIES BETA HCG EXTENDED RANGE ACCESSORY KIT 07/09/1985
K912534 ABBOTT LABORATORIES IMX HCG 07/01/1991
K900327 ABBOTT LABORATORIES IMX HCG (LIST #03A63) 04/18/1990
K894182 ABBOTT LABORATORIES IMX TOTAL B-HCG 09/26/1989
K912535 ABBOTT LABORATORIES IMX TOTAL B-HCG 07/01/1991
K954029 ABBOTT LABORATORIES TESTPACK PLUS HCG URINE 10/05/1995
K031048 ACCESS BIO INCORPORATE CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST 06/16/2003
K980736 ACON LABORATORIES CO. ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST 04/16/1998
K993065 ACON LABORATORIES, INC. ACON COMBO PREGNANCY 10/08/1999
K993317 ACON LABORATORIES, INC. ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE) 12/01/1999
K993203 ACON LABORATORIES, INC. ACON ONE STEP PREGNANCY TEST STRIP (URINE) 12/01/1999
K041946 ACON LABORATORIES, INC. ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE 08/16/2004
K911047 ADEZA BIOMEDICAL OBA(TM) SERUM HCG ASSAY 06/24/1991
K994227 ADVANTAGE DIAGNOSTICS CORP. ADVANTAGE HCG TEST (URINE/SERUM) 02/03/2000
K984080 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST 02/16/1999
K984077 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW PREGNANCY COMBO TEST 02/16/1999
K984079 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST 02/16/1999
K984076 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW PREGNANCY URINE TEST 02/16/1999
K021386 ALIDEX, INC. POLY STAT HCG DIPSTICK TEST 08/05/2002
K030430 ALIDEX, INC. POLY STAT SERUM/URINE HCG TEST 04/18/2003
K871308 ALLELIX, INC. ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT 06/11/1987
K852437 AMERICAN BIOCLINICAL, INC. VISUAL SERUM/URINE HCG COMBO KIT 07/12/1985
K850570 AMERICAN DADE STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY 04/02/1985
K922290 AMERICAN MEDICAL PRODUCTS, INC. SINGLE-STEP PREGNANCY, HCG TEST 07/09/1992
K061257 AMERITEK USA, INC. DBEST HCG PANEL TEST KIT 05/04/2007
K001215 AMERITEK, INC. DBEST HCG 2 IU/ML TEST KIT 06/22/2000
K973957 AMERITEK, INC. DBEST ONE-STEP HCG SERUM/URINE TEST 12/17/1997
K821031 AMERSHAM CORP. AMERLEX B-LCG RIA KIT 05/03/1982
K852675 AMERSHAM CORP. AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT 07/22/1985
K881355 AMERSHAM CORP. AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT 06/08/1988
K923030 ANI OY ANI BIOCARD HCG TEST 09/15/1992
K070921 APPLIED DNA TECHNOLOGIES, INC. BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG 06/29/2007
K071030 APPLIED DNA TECHNOLOGIES, INC. BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC 06/29/2007
K802999 ARMKEL, LLC. BETA-TEC QUALITATIVE 12/22/1980
K823753 ARMKEL, LLC. GENESIS B-HCG 01/24/1983
K850992 ARMKEL, LLC. PREGNA-ZYME 05/01/1985
K152768 ASSURE TECH. CO., LTD. Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip 02/24/2016
K964574 ATHENA MEDICAL CORP. AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST 01/21/1997
K023944 BAYER CORP. BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST 02/11/2003
K971209 BAYER CORP. CLINITEK HCG TEST STRIPS 04/04/1997
K032563 BAYER HEALTHCARE, LLC CLINITEST HCG PREGNANCY TEST 12/23/2003
K870627 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC AFFINITY (TM) HCG IMMUNIT (TM) 05/28/1987
K873524 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC AFFINITY HCG IMMUNIT (POLYCLONAL) 10/06/1987
K902720 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC AFFINITY HCG TEST SYSTEM 08/09/1990
K830997 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ARIA II I-HCG 06/02/1983
K830695 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BETA-COTE B-HCG PREGNANCY SCREENING SYS 03/29/1983
K871700 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC HCG MAB SOLID PHASE COMPONENT SYSTEM 07/15/1987
K811421 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC HCG RADIOIMMUNOASSAY KIT (125I) 07/10/1981
K864591 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC HCG SOLID PHASE COMPONENT SYSTEM 02/04/1987
K901045 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC HCG SOLID PHASE COMPONENT SYSTEM 03/29/1990
K023480 BECKMAN COULTER, INC. ACCESS TOTAL BHCG 12/20/2002
K980173 BECKMAN INSTRUMENTS, INC. ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 03/18/1998
K842654 BECKMAN INSTRUMENTS, INC. EPSILON HCG TEST KIT MONOCLONAL 10/01/1984
K915197 BECTON DICKINSON ADVANCED DIAGNOSTICS PRECISE TM HCG 12/17/1991
K915200 BECTON DICKINSON ADVANCED DIAGNOSTICS PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA 12/16/1991
K926356 BECTON DICKINSON ADVANCED DIAGNOSTICS PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG 03/18/1993
K904016 BHC BIOTECH LTD. MAXI TEST 10/15/1990
K872728 BINAX, INC. BINAX IRMA TOTAL BETA-HCG TEST KIT 08/05/1987
K921212 BIO CLINIC CO. MIRCO ELISA HPL TEST KIT 05/07/1992
K921211 BIO CLINIC CO. NOW PREGNANCY TEST KIT 05/07/1992
K920918 BIO CLINIC CO. TMB CHROMOGEN/SUBSTRATE REAGENT SET 04/07/1992
K831221 BIO GENEX LABORATORIES RIAGEN B-HCG RIA KIT 06/02/1983
K882155 BIO-RAD COTUBE HCG IRMA TEST 08/08/1988
K852201 BIO-RAD ECHOCLONAL HCG IRMA 06/28/1985
K926198 BIO-RAD LABORATORIES, INC. ACCESS TOTAL BHCG ASSAY 02/08/1993
K954732 BIO-RAD LABORATORIES, INC. ACCESS TOTAL BHCG ASSAY (MODIFICATION) 11/20/1995
K991741 BIOCHECK, INC. BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 07/22/1999
K954065 BIOCHEM IMMUNOSYSTEMS (U.S.), INC. BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT 07/10/1996
K822515 BIOCLINICAL GROUP B-HCG RADIOIMMUNOASSAY KIT 09/14/1982
K822840 BIOCLINICAL GROUP RADIOIMMUNOASSAY, HUMAN CHORRIONIC 10/27/1982
K854059 BIOCLINICAL SYSTEMS, INC. MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO 01/13/1986
K910420 BIOCLONE AUSTRALIA PTY LTD. BIOCLONE'S ELEGANCE HCG ELISA KIT 02/26/1991
K882002 BIOGENEX LABORATORIES PREGNAGEN(TM) 09/09/1988
K884880 BIOGENEX LABORATORIES PREGNAGEN(TM) 01/13/1989
K821234 BIOGENEX LABORATORIES RIAGEN B-HCG RIA 05/21/1982
K821657 BIOGENEX LABORATORIES RIAGEN B-HCG RIA 07/13/1982
K992915 BIOMEDICAL PRODUCTS CORP. ONE-STEP DOUBLE-CHEK PREGNANCY TEST 11/18/1999
K003856 BIOMERICA, INC. EZ-HCG URINE(PREGNANCY TEST) 02/21/2001
K012559 BION DIAGNOSTIC SCIENCES POLY STAT HCG TEST 10/16/2001
K960992 BIONIKE LABORATORIES, INC. BIONIKE A/Q PREGNANCY TEST 04/25/1996
K954901 BIONIKE LABORATORIES, INC. BIONIKE A/Q PREGNANCY TEST 12/11/1995
K013194 BIOTECH ATLANTIC, INC. UNIMARK HCG COMBO PREGNANCY TEST 10/10/2001
K896901 BOEHRINGER MANNHEIM CORP. ENZYMUN TEST R HCG 02/08/1990
K955266 BOEHRINGER MANNHEIM ITALIA SPA ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT 02/29/1996
K935502 BOEHRINGER MANNHEIM ITALIA SPA EVENT TEST STRIP HCG 01/27/1994
K831604 BTC DIAGNOSTICS, INC. HCG ACCU-STICK 07/19/1983
K810214 BURROUGHS WELLCOME CO. DAC-CEL DIAGNATAL 03/06/1981
K810215 BURROUGHS WELLCOME CO. DAC-CEL HCG 04/17/1981
K854989 CANWEST MEDICTEX, INC. CANWEST-PREGBLUE 01/13/1986
K992397 CENOGENICS CORP. ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE 08/26/1999
K951136 CHARLTON ASSOC. BIONIKE A/Q PREGNANCY TEST 04/20/1995
K011550 Chembio Diagnostic Systems, Inc. HCG STAT PAK ULTRA-FAST 08/14/2001
K923925 CHEMBIO DIAGNOSTIC SYSTEMS, INC. HCG STAT-PAK 12/24/1992
K123844 CHEMTRON BIOTECH, INC. CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST 05/30/2013
K925277 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS HCG IMMUNOASSAY 03/19/1993
K904123 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS HCG IMMUNOASSAY 10/03/1990
K883927 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MAGIC LITE HCG IMMUNOASSAY 10/13/1988
K822152 CLINETICS CORP. HCG BETA RIA KIT 09/02/1982
K823313 CLINICAL ASSAYS, INC. IN VITRO GAMMACOAT B-HCG RADIO. TEST 12/22/1982
K854024 CORNING MEDICAL & SCIENTIFIC CORNING MAGIC MAB HCG RADIOIMMUNOASSAY 11/26/1985
K820321 CORNING MEDICAL & SCIENTIFIC IMMOPHASE B HCG RADIOIMMUNOASSAY 03/11/1982
K822343 DIAGNOSTIC PRODUCTS CORP. B-HCG 09/02/1982
K894941 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT (TM) HCG IRMA 10/25/1989
K870106 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS 03/13/1987
K874033 DIAGNOSTIC PRODUCTS CORP. IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X 01/05/1988
K895809 DIAGNOSTIC PRODUCTS CORP. MILENIA(TM) HCG (MKCG1,5) 12/01/1989
K020128 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 03/01/2002
K961911 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE I-HCG ELISA 06/28/1996
K960357 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE I-HCG IRMA 05/07/1996
K781310 DIAGNOSTICS BIOCHEM CANADA, INC. HUMAN CHORIONIC GONADO.-BETA RIA KIT 08/31/1978
K880410 DISEASE DETECTION INTERNATIONAL, INC. HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT 04/05/1988
K895912 DISEASE DETECTION INTERNATIONAL, INC. IMMUNOCARD HCG II-S TEST KIT 12/01/1989
K911826 DISEASE DETECTION INTERNATIONAL, INC. IMMUNOCARD HCG ONE STEP (I-S) TEST KIT 07/19/1991
K881709 DISEASE DETECTION INTERNATIONAL, INC. IMMUNOCARD(TM) HCG II TEST KIT 07/08/1988
K925125 DISEASE DETECTION INTERNATIONAL, INC. PRO-STEP HCG 01/13/1993
K925303 DISEASE DETECTION INTERNATIONAL, INC. PRO-STEP PT HCG 06/15/1993
K870672 E.I. DUPONT DE NEMOURS & CO., INC. ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD 04/01/1987
K922697 E.I. DUPONT DE NEMOURS & CO., INC. DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD 08/10/1992
K920505 EASTMAN KODAK COMPANY AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR 03/23/1992
K936287 EASTMAN KODAK COMPANY KODAK SURECELL HCG URINE TEST, MODIFICATION 04/08/1994
K936138 EASTMAN KODAK COMPANY KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION 04/08/1994
K915701 EASTMAN KODAK COMPANY KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION 01/27/1992
K874388 EASTMAN KODAK COMPANY KODAK SURECELL(TM) HCG-URINE KIT 02/08/1988
K902136 EASTMAN KODAK COMPANY KODAK SURECELL(TM) HCG-URINE TEST KIT 06/28/1990
K902681 ENVIRONMENTAL DIAGNOSTICS, INC. EZ-SCREEN:HCG 08/09/1990
K942464 EUCARDIO LABORATORY, INC. UC QIK 1-STEP HCG TEST 09/20/1994
K926500 EUCARDIO LABORATORY, INC. UC QIK PREGNANCY TEST 06/07/1993
K970424 EXCEL SCIENTIFIC, INC. EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST 03/06/1997
K963231 EXCEL SCIENTIFIC, INC. EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST 12/04/1996
K971122 GENIX BIOTEK, INC. ACCULINE PREGNANCY TEST 04/25/1997
K964633 GENIX BIOTEK, INC. ACCUPACK PREGNANCY TEST 02/20/1997
K023544 GENZYME CORP. GENZYME CONTRAST II HCG URINE/SERUM TEST 01/16/2003
K964155 GENZYME DIAGNOSTICS CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST 11/25/1996
K964156 GENZYME DIAGNOSTICS CONTRAST STRIP HCG 11/25/1996
K043385 GENZYME DIAGNOSTICS OSOM HCG COMBO TEST 04/12/2005
K981165 GERMAINE LABORATORIES, INC. AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST 04/16/1998
K980531 GERMAINE LABORATORIES, INC. AIMSTEP PREGNANCY 03/06/1998
K954993 GUARDIAN SCIENTIFIC, CORP. QUIX RAPID PREGNANCY STRIP TEST 12/13/1995
K850727 HOFFMANN-LA ROCHE, INC. BHCG-ROCHE EIA 06/25/1985
K811116 HOFFMANN-LA ROCHE, INC. HCG RADIOIMMUNOASSAY 05/13/1981
K791206 HOFFMANN-LA ROCHE, INC. HCG RIA PREGNANCY TEST 07/30/1979
K820613 HOFFMANN-LA ROCHE, INC. ROCHE B-HCG RIA 04/01/1982
K820614 HOFFMANN-LA ROCHE, INC. ROCHE B-HCG STANDARDS 04/01/1982
K801244 HOFFMANN-LA ROCHE, INC. ROCHE HCG STANDARDS 06/20/1980
K820942 HOFFMANN-LA ROCHE, INC. ROCHE(R) B-HCG RIA URINE STANDARD 05/03/1982
K843407 HYBRITECH, INC. ENCORE HCG REAGENT 10/04/1984
K830138 HYBRITECH, INC. TANDEM E GCG VISUAL END POINT INNUMOENZ 02/07/1983
K842633 HYBRITECH, INC. TANDEM FAST VISUAL HCG ASSAY KIT - 08/23/1984
K821944 HYBRITECH, INC. TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT 07/22/1982
K820822 HYBRITECH, INC. TANDEM HCG KIT 04/29/1982
K850159 HYBRITECH, INC. TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT 03/04/1985
K860542 HYBRITECH, INC. TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT 03/05/1986
K812461 HYBRITECH, INC. TANDEM QUALITATIVE HCG KIT 10/13/1981
K833194 HYBRITECH, INC. TANDEM R-TOTAL B-GCG KIT 01/18/1984
K834000 HYBRITECH, INC. TANDEM VISUAL HCG IMMUNOENZYMETRIC 02/03/1984
K871235 HYBRITECH, INC. TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT 06/03/1987
K870521 HYBRITECH, INC. TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY 04/08/1987
K863861 HYBRITECH, INC. TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA 11/21/1986
K865057 HYBRITECH, INC. TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY 03/10/1987
K881005 ICN BIOMEDICALS, INC. IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG 05/27/1988
K811398 IMMUCHEM CORP. EARLY PREGNANCY DETECTION 05/29/1981
K854104 IMMUNCHEM CORP. IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY) 12/05/1985
K910349 IMMUNOCORP IMMUNOCORP COATED TUBE IRMA HCG 03/21/1991
K041728 IMMUNOSTICS, INC. HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE 08/11/2004
K992695 INBIOS INTL., INC. INSURE PRO TEST 10/18/1999
K050741 IND DIAGNOSTIC INC. IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT 05/16/2005
K052694 IND DIAGNOSTIC INC. ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. 12/16/2005
K062361 INNOVACON, INC. INNOVACON HCG UKTRA TEST DEVICE 10/23/2006
K963132 INTERNATIONAL NEWTECH DEVELOPMENT, INC. MINI STRIP/SERUM HCG 11/18/1996
K951705 INTERNATIONAL NEWTECH DEVELOPMENT, INC. MINISTRIP HCG 10/03/1995
K974060 INTERNATIONAL NEWTECH DEVELOPMENT, INC. MINISTRIP/ SERUM AND URINE COMBO HCG TEST 04/09/1998
K974009 INTERNATIONAL NEWTECH DEVELOPMENT, INC. PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG 03/13/1998
K963133 INTERNATIONAL NEWTECH DEVELOPMENT, INC. PS-UNIT CASSETTE/SERUM HCG 11/18/1996
K130456 JAMES NGUYEN WUNDER PREGNANCY TEST 04/08/2014
K931698 KING'S BAY INTL., INC. KINGS BAY PRELUDE ONE STEP HCG COMBO KIT 11/05/1993
K790397 LEECO DIAGNOSTICS, INC. CONCEP-7-B-HCG 05/23/1979
K812156 LEECO DIAGNOSTICS, INC. CONCEP-7-BHCG 08/20/1981
K792308 LEECO DIAGNOSTICS, INC. CONCEP-7-BHCG 12/06/1979
K880577 LEECO DIAGNOSTICS, INC. CONCEP-7-BHCG 03/15/1988
K844153 LEECO DIAGNOSTICS, INC. CONCEP-7-BHCG (EIA) 12/14/1984
K850531 LEECO DIAGNOSTICS, INC. LEECO CONCEP-7-BHCG EIA 04/02/1985
K850530 LEECO DIAGNOSTICS, INC. LEECO CONCEP-7-BHCG IRMA 04/02/1985
K850201 LEECO DIAGNOSTICS, INC. LEECO CONCEP-7-BHCG LEIAD II 03/04/1985
K863933 LEECO DIAGNOSTICS, INC. VIS-CUBE HCG (EIA) 12/15/1986
K870259 LEECO DIAGNOSTICS, INC. VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 03/10/1987
K852760 LKB INSTRUMENTS, INC. LBK 1244 DELFIA HCG KIT 12/05/1985
K901484 LONDON DIAGNOSTICS, INC. LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC 05/01/1990
K031445 MAINLINE TECHNOLOGY, INC. MAINLINE MAXIE HCG URINE PREGNANCY TEST 07/01/2003
K781578 MALLINCKRODT CRITICAL CARE RIA QUANT B-HCG TEST KIT 10/10/1978
K840328 MEDICAL & SCIENTIFIC DESIGNS, INC. PHASE II HCG KIT 04/19/1984
K952319 MEDIX BIOTECH, INC. CONTRAST & RAPID HCG URINE/SERUM TST 06/20/1995
K932758 MEDIX BIOTECH, INC. MEDIX BIOTECH BESTEST HCG-URINE TEST KIT 09/28/1993
K924259 MEDIX BIOTECH, INC. MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 11/25/1992
K920253 MEDIX BIOTECH, INC. MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT 02/14/1992
K914696 MEDIX BIOTECH, INC. MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011 11/13/1991
K860490 MEDIX BIOTECH, INC. MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY 03/05/1986
K850987 MEDIX BIOTECH, INC. MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM 04/08/1985
K850949 MEDIX BIOTECH, INC. MEDIX VISUAL URINE HCG (7/7) TEST 04/12/1985
K896587 MEDIX BIOTECH, INC. MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT 02/16/1990
K801491 MICROANALYTIC RESEARCH, INC. MRI HCG-BETA RIA KIT CAT. #MR-10100 08/13/1980
K831264 MICROMEDIC SYSTEMS BHCG RIA KIT 06/08/1983
K943859 MIZUHO USA, INC. QUICK CHECKER HCG PREGNANCY TEST 02/10/1995
K853258 MODERN DIAGNOSTICS, INC. BETA-HCG MICROTITER PREGNANCY TEST 10/01/1985
K853006 MODERN DIAGNOSTICS, INC. HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY 09/04/1985
K772039 MONITOR SCIENCE CORP. BETA-HCG RIA 11/23/1977
K854958 MONOBIND HCG RIA TEST SYSTEM 01/28/1986
K850730 MONOCLONAL ANTIBODIES, INC. MODEL SERUM HCG ASSAY 04/02/1985
K822520 MONOCLONAL ANTIBODIES, INC. MODEL UCG ASSAY 09/28/1982
K854611 MONOCLONAL ANTIBODIES, INC. RAMP URINE HCG ASSAY 12/30/1985
K832562 MONOCLONAL ANTIBODIES, INC. SERUM HCG ASSAY 09/12/1983
K112315 NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD HOME PREGNANCY TEST 04/23/2012
K872390 NICHOLS INSTITUTE DIAGNOSTICS ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM 09/02/1987
K842499 NMS PHARMACEUTICALS, INC. NMS 1043 ENZYME IMMUNOASSAY KIT 09/14/1984
K853925 NMS PHARMACEUTICALS, INC. QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA 12/02/1985
K790138 NUCLEAR MEDICAL LABORATORIES, INC. CHORIC-SHURE 03/12/1979
K820523 NUCLEAR MEDICAL LABORATORIES, INC. CHORIO-QUANT 03/15/1982
K810936 NUCLEAR MEDICAL LABORATORIES, INC. CHORIO-SHURE 04/17/1981
K792197 NUCLEAR MEDICAL LABORATORIES, INC. HUMAN CHORIONIC GONADOTROPIN (RIA) 12/06/1979
K832892 NUCLEAR MEDICAL LABORATORIES, INC. MODIFIED CHORIO-SHURE 10/28/1983
K780679 NUCLEAR MEDICAL SYSTEMS, INC. B-HCG-RIA 06/14/1978
K831109 ORGANON, INC. DUOCLON SLIDE TEST 06/02/1983
K841525 ORGANON, INC. OREIA II B-HCG PREGNANCY TEST KIT 06/05/1984
K832801 ORGANON, INC. OREIA II B-HCG, ENZYME INNUNOASSAY 12/08/1983
K772086 ORGANON, INC. QUANTROLS HCG 11/23/1977
K894420 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO RESULT PLUS/PREGNANCY 10/04/1989
K872730 ORTHO DIAGNOSTIC SYSTEMS, INC. RESULT PLUS/HCG PREGNANCY TEST 10/20/1987
K852327 PACIFIC BIOTECH, INC. BETA QUIK STAT 08/20/1985
K860965 PACIFIC BIOTECH, INC. BETA QUIK STICK 04/24/1986
K843795 PACIFIC BIOTECH, INC. BETA QUIK V 10/30/1984
K831223 PACIFIC BIOTECH, INC. BETA-QUIK-15 RIA KIT 06/02/1983
K895390 PACIFIC BIOTECH, INC. CARDS O.S. (TM) HCG-URINE 11/13/1989
K873788 PACIFIC BIOTECH, INC. CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504 11/23/1987
K863199 PACIFIC BIOTECH, INC. CARDS(TM) HCG-URINE 09/15/1986
K884616 PACIFIC BIOTECH, INC. FIRSTDAY EARLY PREGNANCY TESTING KIT II 01/13/1989
K881015 PACIFIC BIOTECH, INC. FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT 08/29/1988
K891770 PACIFIC BIOTECH, INC. HCG IRMA II 05/24/1989
K862007 PACIFIC BIOTECH, INC. HCG IRMA, CAT. NO. CR-1501 07/01/1986
K883639 PACIFIC BIOTECH, INC. MODIFIED HCG IRMA KIT 10/06/1988
K831302 PACIFIC BIOTECH, INC. PBI BHCG RIA KIT 06/08/1983
K020968 PAN PROBE BIOTECH, INC. LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD 07/15/2002
K901935 PB DIAGNOSTIC SYSTEMS, INC. OPUS (TM) HCG 06/26/1990
K932279 PB DIAGNOSTIC SYSTEMS, INC. OPUS(R) TOTAL B-HCG TEST SYSTEM 07/08/1993
K830526 PCL-RIA, INC. B-GCG SYSTEM BY RIA 04/05/1983
K790863 PCL-RIA, INC. HUMAN CHORIONIC GONADOTROPHIN STANDARDS 07/17/1979
K790876 PCL-RIA, INC. LABELED HUMAN CHORIONIC GONADOTROPHIN 07/17/1979
K790864 PCL-RIA, INC. RABBIT ANTISERUM TO HUMAN CHORIONIC 07/17/1979
K991095 PHAMATECH QUICKCARD HCG COMBO TEST, MODEL #9014 04/28/1999
K980896 PHAMATECH QUICKCARD PRO HCG TEST, MODEL 9008 04/02/1998
K974615 PHAMATECH QUICKSTICK PRO HCG TEST 01/26/1998
K112101 POLYMED THERAPEUTICS, INC FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS 07/17/2012
K132834 POLYMED THERAPEUTICS, INC FASTEP S10 HCG SERUM/URINE COMBO TEST 01/09/2014
K981443 PRINCETON BIOMEDITECH CORP. BIOSIGN HCG I - ONE STEP PREGNANCY TEST 06/25/1998
K944426 PRINCETON BIOMEDITECH CORP. BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE 10/25/1994
K981444 PRINCETON BIOMEDITECH CORP. BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP 07/22/1998
K050955 PRINCETON BIOMEDITECH CORP. LIFESIGN DXPRESS, MODEL LSR2000 01/23/2006
K020439 PRINCETON BIOMEDITECH CORP. STATUS HCG SERUM/URINE 05/23/2002
K901011 PRINCETON BIOMEDIX BIOSIGN HCG-ONE STEP PREGNANCY TEST 05/04/1990
K894705 PRINCETON BIOMEDIX BIOSPOT HCG-RAPID PREGNANCY TEST 10/18/1989
K894750 PRINCETON BIOMEDIX BIOSTIX I. HCG - ONE STEP PREGNANCY TEST 10/18/1989
K881806 QUADRA LOGIC TECHNOLOGIES, INC. QLT ABSOLUTE URINE-HCG PREGNANCY TEST 08/02/1988
K072264 Qualigen, Inc. FASTPACK HCG IMMUNOASSAY 12/06/2007
K954273 QUIDEL CORP. CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG 10/16/1995
K973858 QUIDEL CORP. CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO 11/26/1997
K972748 QUIDEL CORP. CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE 08/29/1997
K913122 QUIDEL CORP. DIRECTIGEN 1-2-3(TM) HCG TEST 08/16/1991
K890615 QUIDEL CORP. DIRECTIGEN1-2-3 BHCG PREGNANCY TEST 04/18/1989
K882086 QUIDEL CORP. QTEST(TM) PREGNANCY 07/28/1988
K844082 QUIDEL CORP. QUEST BETA HCG ENZYME IMMUNOASSAY KIT 11/21/1984
K932042 QUIDEL CORP. QUICKVUE ONE-STEP HCG COMBO 06/29/1993
K925435 QUIDEL CORP. QUICKVUE ONE-STEP HCG TEST 12/03/1992
K020801 QUIDEL CORP. QUICKVUE ONE-STEP HCG-COMBO 05/17/2002
K973841 QUIDEL CORP. QUICKVUE ONE-STEP HCG-COMBO 12/01/1997
K972742 QUIDEL CORP. QUICKVUE ONE-STEP HCG-URINE 08/29/1997
K020799 QUIDEL CORP. QUICKVUE ONE-STEP HCG-URINE 05/17/2002
K974052 QUIDEL CORP. QUICKVUE SEMI-Q HCG-COMBO 12/19/1997
K842692 QUIDEL CORP. QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT 09/05/1984
K894790 QUIDEL CORP. QUIDEL HCG TEST 10/25/1989
K881595 QUIDEL CORP. QUIDEL PREGNANCY TEST 05/27/1988
K945969 QUIDEL CORP. RAPIDVUE(TM) HCG 01/27/1995
K131166 QUIDEL CORP. SOFIA(R) HCG FIA 08/02/2013
K102175 QUIDEL CORPORATION RAPIDVUE HCG TEST 08/25/2010
K781487 RADIOASSAY SYSTEMS LABORATORIES, INC. EARLY PREGNANCY DETECTION KIT 10/11/1978
K981770 RAPID DIAGNOSTICS, INC. RAPIDHCG PREGNANCY TEST 06/05/1998
K990684 SA SCIENTIFIC, INC. MODIFICATION OF SAS SERUM/URINE HCG 05/10/1999
K022683 SA SCIENTIFIC, INC. SAS BLOOD/SERUM/URINE/URINE HCG 12/16/2002
K926204 SA SCIENTIFIC, INC. SAS ONE STEP PREGNANCY 02/02/1993
K964995 SA SCIENTIFIC, INC. SAS ONE-STEP PREGNANCY 01/21/1997
K990741 SA SCIENTIFIC, INC. SAS ONE-STEP PREGNANCY 05/10/1999
K931302 SA SCIENTIFIC, INC. SAS PREGNANCY STRIP 06/09/1993
K020438 SA SCIENTIFIC, INC. SAS VALUE HCG 03/08/2002
K010593 SA SCIENTIFIC, INC. SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT 04/05/2001
K010522 SA SCIENTIFIC, INC. SUREVUE URINE HCG 07/31/2001
K980205 SAN DIEGO BIOTECH SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST 02/12/1998
K974851 SAN DIEGO BIOTECH SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST 01/22/1998
K965253 SASCIE SAS PREGNANCY STRIP 02/18/1997
K965250 SASCIE SAS SERUM/URINE HCG 02/18/1997
K962906 SCRIPPS LABORATORIES, INC. SCRIPPS LABORATORIES HCG ONE-STEP 08/23/1996
K862262 SERONO DIAGNOSTICS, INC. HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS 07/29/1986
K873033 SERONO DIAGNOSTICS, INC. HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE 09/14/1987
K781733 SERONO LABORATORIES, INC. RIA KIT, PREG-STAT 12/20/1978
K894175 SERONO-BAKER DIAGNOSTICS, INC. SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY 12/19/1989
K172322 Siemens Healthcare Diagnostics Inc. Atellica IM Total hCG (ThCG) 03/29/2018
K991067 SIMEX MEDICAL, INC. MODIFICATION OF: DAVIDSTRIP HCG 04/27/1999
K981512 SKD, INC. A BECKMAN COULTER CO. ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025 05/28/1998
K020378 STANBIO LABORATORY QUPID PLUS E.R. 06/21/2002
K963408 SUN BIOMEDICAL LABORATORIES, INC. VISUALINE D HCG 10/18/1996
K943239 SUN BIOMEDICAL LABORATORIES, INC. VISUALINE II HCG 12/07/1994
K841854 SYNCOR INTL. CORP. BHCG RIA 06/22/1984
K833851 SYNCOR INTL. CORP. HCG RIA 03/19/1984
K842598 SYNCOR INTL. CORP. STAR HCG MONOCLONAL ANTIBODY IMMUNO 07/26/1984
K832796 SYNCOR INTL. CORP. STAR HCG MONOCLONAL ANTIBODY IMMUNORAD 01/24/1984
K945951 SYNTRON BIORESEARCH, INC. QUIKPAC II, ONE STEP HCG COMBO KIT 02/08/1995
K870751 SYNTRON BIORESEARCH, INC. SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST 05/20/1987
K865076 SYNTRON BIORESEARCH, INC. SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST 02/11/1987
K872130 SYVA CO. ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES 07/16/1987
K926342 SYVA CO. VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY 02/17/1993
K923123 TCPI, INC. HCG PREGNANCY ONE STEP TEST STRIP 09/09/1992
K955353 TCPI, INC. ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT 03/19/1996
K923376 TECH-CO, INC. VISUAL HCG PREGNANCY TEST 10/01/1992
K964461 TECO DIAGNOSTICS ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST 02/11/1997
K936031 TECO DIAGNOSTICS ONE STEP PREGNANCY TEST 04/15/1994
K964536 TECO DIAGNOSTICS ONE-STEP DIPSTICK PREGNANCY TEST 02/11/1997
K964462 TECO DIAGNOSTICS ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST 02/11/1997
K841821 TRAVENOL LABORATORIES, S.A. CA-1511, IN VITRO RADIOIMMUNOASSAY 06/22/1984
K801409 TRAVENOL LABORATORIES, S.A. GAMMADAB B-HCG RADIOIMMUNOASSAY KIT 07/14/1980
K172257 True Diagnostics, Inc TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) 12/22/2017
K993703 UNIPATH LTD. CLEARVIEW EASY HCG PREGNANCY TEST 12/02/1999
K924673 UNIPATH LTD. CLEARVIEW HCG 05/11/1993
K883777 UNIPATH LTD. CLEARVIEW HCG 10/06/1988
K905741 UNIPATH LTD. CLEARVIEW HCG SERUM/URINE 05/15/1991
K914240 UNIPATH LTD. CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF 10/25/1991
K851076 UNITED BIOTECH, INC. UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST 05/10/1985
K864174 UNITED BIOTECH, INC. UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE 03/13/1987
K981838 UNOTECH DIAGNOSTICS, INC. ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002 06/25/1998
K032987 UNOTECH DIAGNOSTICS, INC. ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005 11/17/2003
K971886 UNOTECH DIAGNOSTICS, INC. ACCUTEST HCG-URINE 06/11/1997
K862247 V-TECH, INC. TARGET HCG, ENZYME IMMUNOASSAY REAGENTS 07/29/1986
K903937 V-TECH, INC. TARGET(TM) HOG ONE STEP 10/22/1990
K890131 V-TECH, INC. TARGET(TM) QUANTITATIVE HCG 03/09/1989
K914303 V-TECH, INC. TARGET(TM)-HOG 10/11/1991
K894012 VANGUARD BIOMEDICAL CORP. MINICLINIC PREGNANCY TEST 07/25/1989
K914253 VANGUARD BIOMEDICAL CORP. PROCLINIC ONE STEP PREGNANCY TEST 10/11/1991
K930014 VANGUARD BIOMEDICAL CORP. PROCLINIC ONE-STEP DIPSTICK PREGNANCY TEST 03/25/1993
K841023 VENTREX LABORATORIES, INC. COATED TUBE HCG IMMUNOASSAY HCG 05/01/1984
K874258 VENTREX LABORATORIES, INC. VENTRESCREEN, HCG URINE 11/23/1987
K890549 VENTREX LABORATORIES, INC. VENTREX COATED TUBE HCG 03/28/1989
K841081 VENTREX LABORATORIES, INC. VENTREZYME BETA-HCG IMMUNOASSAY HCG 05/07/1984
K013702 VICTORCH MEDITEK, INC. VICTORCH HCG TEST STRIP 12/27/2001
K921302 VITEK SYSTEMS, INC. VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM 07/28/1992
K853748 VXR, INC. VENTRESCREEN HCG URINE 10/01/1985
K833960 VXR, INC. VENTREX PREGNANCY TEST KIT ENZYME 02/03/1984
K051841 W.H.P.M., INC. WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST 08/22/2005
K012284 W.H.P.M., INC. WH ACCU TEST PREGNANCY TEST 08/28/2001
K781794 WAMPOLE LABORATORIES BETA-TEC 12/29/1978
K760336 WAMPOLE LABORATORIES BIOCEPT-G 11/12/1976
K830203 WELLCOME DIAGNOSTICS DAC-CEL DIAGNATAL RD 50 02/18/1983
K973879 WYNTEK DIAGNOSTICS, INC. OSOM CARD HCG-URINE TEST 11/04/1997
K990578 WYNTEK DIAGNOSTICS, INC. OSOM CARD II HCG-URINE TEST, MODEL 102 03/09/1999
K965227 WYNTEK DIAGNOSTICS, INC. OSOM CLASSIC HCG-URINE TEST (115) 02/04/1997
K974159 WYNTEK DIAGNOSTICS, INC. OSOM HCG-URINE TEST MODEL 101 12/24/1997
K953383 WYNTEK DIAGNOSTICS, INC. WYNTEK OSOM HCG-URINE TEST 08/29/1995
K033297 ZBX CORPORATION ZAP HCG TEST, MODEL 8001 03/18/2004
K023823 ZER HITECH EASYCUP 05/22/2003


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact