FDA 510(k) Applications for Medical Device Product Code "CEP"
(Radioimmunoassay, Luteinizing Hormone)

FDA 510(k) Number Applicant Device Name Decision Date
K884138 ABBOTT LABORATORIES ABBOTT IMX LH 11/29/1988
K890510 ABBOTT LABORATORIES ABBOTT OVULATION PREDICTOR TEST 03/24/1989
K012252 ACON LABORATORIES, INC. QUIK-CHECK OVULATION PREDICTOR 08/24/2001
K853142 ADVANCED CARE PRODUCTS OVUTIME OVULATION PREDICTOR TEST 12/17/1985
K022829 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW LH OVULATION PREDICTING TEST 11/05/2002
K852376 AMERICAN BIOCLINICAL, INC. SIMULTANEOUS LH/FSH SYSTEM BY RIA 07/09/1985
K873052 AMERICAN DADE STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY 09/14/1987
K974508 AMERITEK, INC. DBEST ONE-STEP OVULATION TEST 02/02/1998
K820753 AMERSHAM CORP. AMERLEX LH RIA KIT (CODE IM2081) 04/09/1982
K851104 AMERSHAM CORP. AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT 04/10/1985
K880933 AMERSHAM CORP. AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST 07/28/1988
K781685 AMERSHAM CORP. RIA KIT, LH 10/27/1978
K871241 ARMKEL, LLC. ANSWER OVULATION TEST KIT 10/02/1987
K953581 ARMKEL, LLC. FIRST RESPONSE OVULATION PREDICTOR TEST 10/03/1995
K973310 ARMKEL, LLC. TBD* ONE-STEP OVULATION PREDICTOR TEST 10/27/1997
K894279 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST 08/15/1989
K942638 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT 09/07/1994
K962866 BEHRING DIAGNOSTICS, INC. OPUS HLH 08/23/1996
K920920 BIO CLINIC CO. ELISA TUBE LH TEST KIT 04/08/1992
K884498 BIO-RAD COTUBE LH IRMA ASSAY 12/22/1988
K821346 BIO-RAD QUANTIMUNE HLH RIA 05/28/1982
K810302 BIO-RAD QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM 02/25/1981
K940549 BIO-RAD LABORATORIES, INC. ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY 04/06/1994
K853837 BIOCLINICAL GROUP LH/FSH RADIOIMMUNOASSAY KIT 10/16/1985
K860333 BIOCLINICAL SYSTEMS, INC. MICRO-ELISA HLH TEST KIT MONOCLONAL 04/21/1986
K860334 BIOCLINICAL SYSTEMS, INC. VISI-CHECK HLH TEST MONOCLONAL 04/21/1986
K904387 BIOCLONE AUSTRALIA PTY LTD. BIOCLONES ELEGANCE LH ELISA KIT 11/06/1990
K902208 BIOGENEX LABORATORIES MODIFIED OVUGEN 07/17/1990
K873534 BIOGENEX LABORATORIES OVUGEN SURETEST 11/23/1987
K964694 BOEHRINGER MANNHEIM CORP. ELECSYS LH ASSAY 01/24/1997
K900779 BOEHRINGER MANNHEIM CORP. ENZYMUN TEST(R) LH 04/03/1990
K860308 BOOTS-CELLTECH DIAGNOSTICS, INC. SUCROSEP LUTEINIZING HORMONE (LH) IRMA 03/17/1986
K880758 BOOTS-CELLTECH DIAGNOSTICS, INC. SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY 04/18/1988
K841545 BTC DIAGNOSTICS, INC. ENZYME IMMUNOASSAY FOR DETECTION HORM 11/27/1984
K780367 CALBIOCHEM-BEHRING CORP. RIA SYS. FOR HUMAN LUTEINIZING HORMONE 04/28/1978
K862055 CANWEST MEDICTEX, INC. CANWEST OVU-BLUE 01/06/1987
K010244 Chembio Diagnostic Systems, Inc. SURE CHECK OVULATION PREDICTOR 05/02/2001
K962041 CIBA CORNING DIAGNOSTICS CORP. ACS LH2 IMMUNOASSAY 06/21/1996
K910198 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS LH IMMUNOASSAY 02/04/1991
K902398 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MAGIC LITE LH IMMUNOASSAY 06/28/1990
K920411 CIRRUS DIAGNOSTICS, INC. IMMULITE HLH 03/11/1992
K792000 CIS RADIOPHARMACEUTICALS, INC. LUTEINIZING HORMONE (LH) RIA 10/30/1979
K823380 CLINETICS CORP. 125-I LH RADIOIMMUNOASSAY KIT 12/22/1982
K862180 CLINETICS CORP. MODIFIED COTROPIN RADIOIMMUNOASSAY KIT 07/07/1986
K823476 CLINICAL ASSAYS, INC. GAMMADAB LH RADIO-KIT #CA-1508 12/28/1982
K822288 CORNING MEDICAL & SCIENTIFIC LH (125I) RADIOIMMUNOASSAY 09/13/1982
K874624 CYBERFLUOR, INC. FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301 01/11/1988
K900621 CYBERFLUOR, INC. FIAGEN(TM) HLH.S 03/01/1990
K791405 DIAGNOSTIC PRODUCTS CORP. 125I LEUTINIZING HORMONE RIA KIT 09/17/1979
K951748 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT LH IRMA 05/15/1995
K863934 DIAGNOSTIC PRODUCTS CORP. DPC COAT-A-COUNT IRMA LH KIT 02/06/1987
K874032 DIAGNOSTIC PRODUCTS CORP. IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5 12/30/1987
K902786 DIAGNOSTIC PRODUCTS CORP. MILENIA (TM) LH 10/12/1990
K961109 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE LH IRMA 04/05/1996
K943252 DISEASE DETECTION INTERNATIONAL, INC. PRO-STEP LH OVULATION PREDICTION TEST 10/25/1994
K943996 DUPONT MEDICAL PRODUCTS DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD 10/20/1994
K811994 ENDOCRINE-METABOLIC CENTER RADIOIMMUNOASSAY LUTEINIZING HORMONE 07/27/1981
K851332 EURO-DIAGNOSTICS BV BLHI LUTEINIZING HORMONE 07/09/1985
K970467 EXCEL SCIENTIFIC, INC. EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT 03/18/1997
K860984 HYBRITECH, INC. TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT 04/29/1986
K895094 HYBRITECH, INC. TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT 10/31/1989
K872131 HYBRITECH, INC. TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY 08/25/1987
K922944 ICN BIOMEDICALS, INC. IMMUCHEM LH-MW ELISA 02/02/1993
K864144 IMMUCHEM CORP. LUTEINIZING HORMONE (LH-IRMA) RIA KIT 11/24/1986
K811024 IMMUNALYSIS CORPORATION LUTEINIZING HORMONE DIRECT RIA KIT 125/I 05/08/1981
K803278 IMMUNO NUCLEAR CORP. LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT 01/21/1981
K903052 IMMUNOCORP SCIENCES, INC. IMMUNOCORP LH IRMA COATED TUBE 08/29/1990
K896866 IN VITRO DIAGNOSTICS, INC. LUTEINIZING HORMONE-EIA-XT 02/13/1990
K813213 INTL. IMMUNOASSAY LABORATORIES, INC. SHARIA-LH RIA KIT FOR QUANTITATION HORMO 12/22/1981
K964982 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) 02/20/1997
K854838 LEECO DIAGNOSTICS, INC. LEE-BEAD BETA LH (EIA) 01/07/1986
K810662 LEECO DIAGNOSTICS, INC. LEECO LH-QUANT DIAGNOSTIC KIT 03/31/1981
K861354 LEECO DIAGNOSTICS, INC. RIGHT-DAY OVULATION HOME TEST 09/16/1986
K860538 LEECO DIAGNOSTICS, INC. RIGHT-DAY URINARY LH (EIA) 07/29/1986
K855173 LKB INSTRUMENTS, INC. DELFIA TM HLH KIT 02/28/1986
K902443 LONDON DIAGNOSTICS, INC. LUMATAG(TM) LH DIAGNOSTIC KIT 08/02/1990
K013582 MAYBE?MOM MAYBE?MOM MINI OVULATION MICROSCOPE 01/16/2003
K873668 MEDIX BIOTECH, INC. MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT 10/07/1987
K920504 MEDIX BIOTECH, INC. MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT 03/02/1992
K896642 MEDIX BIOTECH, INC. MODIFIED LH ENZYME IMMUNOASSAY TEST KIT 01/30/1990
K820741 MICROANALYTIC RESEARCH, INC. MR1 LUTROPIN RIA KIT 04/14/1982
K840188 MICROMEDIC SYSTEMS MICROMEDIC LH & FSH RIA KIT 03/23/1984
K820760 MONOBIND LH RADIOIMMUNOASSAY TEST SYSTEM 04/16/1982
K850480 MONOCLONAL ANTIBODIES, INC. OVU STICK SELF-TEST -MODIFICATION 03/05/1985
K840412 MONOCLONAL ANTIBODIES, INC. OVU STICK URINE HLH KIT 04/13/1984
K871726 MONOCLONAL ANTIBODIES, INC. OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) 07/27/1987
K843284 MONOCLONAL ANTIBODIES, INC. OVUSTICK SELF-TEST 12/11/1984
K833376 NEW ENGLAND NUCLEAR RIANEN LUTEINIZING HORMONE RIA KIT 12/20/1983
K863679 NICHOLS INSTITUTE DIAGNOSTICS ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM 10/16/1986
K881124 NICHOLS INSTITUTE DIAGNOSTICS ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY 04/18/1988
K935319 NICHOLS INSTITUTE DIAGNOSTICS CHEMILUMINESCENCE LH 04/05/1995
K770854 NICHOLS INSTITUTE DIAGNOSTICS LUTEINIZING HORMONE RIA REAGENT, LH-RIA 05/26/1977
K860828 NMS PHARMACEUTICALS, INC. "FORETEL", COLOR OVULATION TEST 08/04/1986
K851445 NMS PHARMACEUTICALS, INC. COLOR OVULATION TEST 07/29/1985
K840174 PACIFIC BIOTECH, INC. LH QUIK RIA KIT 03/19/1984
K911050 PANTEX, DIV. BIO-ANALYSIS, INC. LH IRMA IMMUNOMAG 04/12/1991
K910717 PANTEX, DIV. BIO-ANALYSIS, INC. PANTEX IRMA LH 1251 KIT 03/19/1991
K913938 PB DIAGNOSTIC SYSTEMS, INC. OPUS(R) LH TEST SYSTEM 11/07/1991
K780576 PCL-RIA, INC. 125-I LABELED HUMAN LUTEINIZING HORMONE 05/19/1978
K810741 PCL-RIA, INC. LUTEINIZING HORMONE 03/31/1981
K820357 PCL-RIA, INC. LUTEINIZING HORMONE KIT 03/25/1982
K810754 PCL-RIA, INC. LUTENIZING HORMONES 03/31/1981
K990249 PHAMATECH OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 03/22/1999
K021409 PHAMATECH INC. AT HOME OVULATION TEST, MODEL 9032 05/24/2002
K883814 PHARMACIA, INC. DELFIA HLH SPEC KIT 03/08/1989
K963693 PRINCETON BIOMEDITECH CORP. OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST 11/29/1996
K930185 PRINCETON BIOMEDIX OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP 03/04/1993
K953063 QUIDEL CORP. CONCEIVE OVULATION PREDICTOR 08/23/1995
K920160 QUIDEL CORP. LH GEN III SELF-TEST/CONCEIVE 03/11/1992
K852146 QUIDEL CORP. QUIDEL QUEST OVULATION TEST 07/29/1985
K800106 RADIOIMMUNOASSAY, INC. LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS 02/13/1980
K930306 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS CORE LH EIA 05/26/1993
K943188 SEALITE SCIENCES, INC. SEALITE SCIENCE, INC. AQUALITE(R) LH 10/20/1994
K964925 SEALITE SCIENCES, INC. SEALITE SCIENCES, INC. AQUALITE LH 01/22/1997
K991466 SELFCARE, INC. EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) 05/25/1999
K991386 SELFCARE, INC. EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) 05/25/1999
K002867 SELFCARE, INC. INVERNESS MEDICAL OVULATION PREDICTOR TEST 10/12/2000
K873186 SERONO DIAGNOSTICS, INC. LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA 09/29/1987
K872727 SERONO DIAGNOSTICS, INC. LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE 08/05/1987
K882340 SERONO DIAGNOSTICS, INC. LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA 08/08/1988
K893605 SERONO-BAKER DIAGNOSTICS, INC. SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY 06/20/1989
K833854 SYNCOR INTL. CORP. LH RIA 01/13/1984
K842445 SYNCOR INTL. CORP. LH RIA 09/04/1984
K951538 SYNTRON BIORESEARCH, INC. BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT 07/11/1995
K983113 SYNTRON BIORESEARCH, INC. BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT 11/18/1998
K871602 SYNTRON BIORESEARCH, INC. MICROCHECK LH OVULATION TEST 06/11/1987
K926394 SYVA CO. VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY 05/26/1993
K883530 TAMBRANDS, INC. FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST 12/19/1988
K013323 TCI NEW YORK TCI-31 LIFELONG OVULATION TESTER 12/05/2001
K935134 TCPI, INC. ONE STEP LH TEST 01/11/1994
K863929 TERUMO MEDICAL CORP. TERUMO SENSIBEAD(TM) EIA HLH KIT 11/13/1986
K792350 UNION CARBIDE CORP. CENTRIA LH RIA 01/16/1980
K871332 UNIPATH LTD. CLEARPLAN 08/05/1987
K894579 UNIPATH LTD. CLEARPLAN EASY 10/12/1989
K981271 UNIPATH LTD. CLEARPLAN EASY OVULATION TEST 06/25/1998
K013874 UNIPATH LTD. CLEARPLANE EASY OVULATION TEST 02/19/2002
K863442 UNITED BIOTECH, INC. UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE 02/04/1987
K910351 VANGUARD BIOMEDICAL CORP. MINICLINIC OVULATION PREDICTION TEST 03/21/1991
K891762 VANGUARD BIOMEDICAL CORP. MINICLINIC OVULATION PREDICTION TEST 07/20/1989
K960233 VANGUARD BIOMEDICAL CORP. MINICLINIC OVULATION PREDICTOR 04/23/1996
K882252 VITEK SYSTEMS, INC. PHASE II LH KIT 08/04/1988
K921176 VITEK SYSTEMS, INC. VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM 04/08/1992
K870584 WARNER-LAMBERT CO. O.P.T.(TM) OVULATION PREDICTION TEST 11/25/1987


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