FDA 510(k) Applications for Medical Device Product Code "DHA"
(System, Test, Human Chorionic Gonadotropin)

FDA 510(k) Number Applicant Device Name Decision Date
K983424 ABBOTT LABORATORIES ABBOTT ARCHEITECT TOTAL B-HCG 12/01/1998
K170317 ABBOTT LABORATORIES Alinity i Total ?-hCG Reagent Kit, Alinity i System 10/23/2017
K884207 ABBOTT LABORATORIES RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO 12/02/1988
K133002 ABBOTT POINT OF CARE INC. i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials 04/16/2015
K031052 ACCESS BIO INCORPORATE CARESTART HCG ONE-STEP PREGNANCY TEST 06/13/2003
K893873 AMPCOR, INC. SINGLE AND DUAL BAND DIPSTICK HCG TEST 08/21/1989
K022681 AZOG, INC. AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE) 11/01/2002
K022680 AZOG, INC. AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK) 11/01/2002
K922073 BAXTER DIAGNOSTICS, INC. STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY 10/19/1992
K893577 BAXTER HEALTHCARE CORP. STATUS HCG FLUOROMETRIC ENZYME 08/03/1989
K913236 BAXTER HEALTHCARE CORP. STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY 08/16/1991
K961351 BAYER CORP. HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD 06/03/1996
K130020 BECKMAN COULTER, INC. ACCESS TOTAL BHCG (5TH IS) 10/01/2013
K961792 BIOCIRCUITS CORP. BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS 08/21/1996
K941090 BIOTECH ATLANTIC, INC. UNISTEP HCG PREGNANCY TEST STRIP 06/02/1994
K961487 BOEHRINGER MANNHEIM CORP. ELECSYS HCG ASSAY 06/12/1996
K862108 BOEHRINGER MANNHEIM CORP. ENZYMUN-TEST HCG 08/19/1986
K911796 CIRRUS DIAGNOSTICS, INC. IMMULITE(TM) HCG 06/20/1991
K063754 DADE BEHRING, INC. DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 02/23/2007
K060548 DADE BEHRING, INC. STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK 04/06/2006
K003696 DADE BEHRING, INC. STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD 01/25/2001
K970387 DADE CHEMISTRY SYSTEMS, INC. HUMAN CHORIONIC GONADOTROPIN METHOD 03/10/1997
K883148 DIAGNOSTIC CHEMICALS, LTD. (USA) IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40 12/05/1988
K033234 DIAGNOSTIC PRODUCTS CORP. IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER 12/12/2003
K990222 DIAGNOSTIC PRODUCTS CORP. IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6 02/26/1999
K994085 DIAGNOSTIC PRODUCTS CORP. IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 01/28/2000
K884430 DIAMEDIX CORP. SERUM HCG MICROASSAY 12/09/1988
K131037 DIASORIN, INC. LIAISON XL HCG 09/06/2013
K163418 Diazyme Laboratories Diazyme DZ-Lite Total beta-hCG Test System 08/18/2017
K955707 EXCEL SCIENTIFIC, INC. ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT 05/02/1996
K013857 GERMAINE LABORATORIES, INC. AIMSTEP PREGNANCY 01/22/2002
K974512 GERMAINE LABORATORIES, INC. AIMSTICK PBD COMBO PREGNANCY 01/02/1998
K974368 GERMAINE LABORATORIES, INC. AIMSTICK PBD PREGNANCY 01/02/1998
K973825 GERMAINE LABORATORIES, INC. MIDSTREAM HOME REGNANCY TEST 12/19/1997
K072500 Guangzhou Wondfo Biotech Co., Ltd. ONE STEP HCG URINE/SERUM TEST 04/21/2009
K882192 HYGEIA SCIENCES HYGEIA URINE PREGNANCY TEST 11/10/1988
K991515 INBIOS INTL., INC. INSURE PREGNANCY TEST 05/28/1999
K952283 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. AMERLITE HCG-60 ASSAY 07/17/1995
K970894 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075) 04/14/1997
K891096 LEECO DIAGNOSTICS, INC. VIS-DISK HCG (EIA) JPL-041M 06/16/1989
K891095 LEECO DIAGNOSTICS, INC. VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M 06/16/1989
K873872 MEDIX BIOTECH, INC. HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013 10/28/1987
K991532 METRIKA, INC. DRX QT. HCG 09/17/1999
K000844 MIZUHO USA, INC. ABSOLUTE HCG PREGNANCY TEST 06/16/2000
K042676 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY 12/17/2004
K080094 OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) OLYMPUS TOTAL BHCG TEST SYSTEN 09/03/2008
K945331 ORGANON TEKNIKA CORP. AURAFLEX HCG 03/20/1995
K063720 ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS 04/09/2007
K882895 PACIFIC BIOTECH, INC. MODIFIED BETA QUIK STAT EIA KIT 10/12/1988
K974425 PRINCETON BIOMEDITECH CORP. BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST 12/24/1997
K950307 PRINCETON BIOMEDITECH CORP. BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST 03/01/1995
K892654 PRINCETON BIOMEDIX BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST 06/19/1989
K003178 ROCHE DIAGNOSTICS CORP. ELECSYS HCG AND BETA TEST SYSTEM 12/14/2000
K002148 ROCHE DIAGNOSTICS CORP. ELECSYS HCG TEST SYSTEM 08/22/2000
K932409 SA SCIENTIFIC, INC. SAS(TM) SERUM/URINE HCG 06/29/1993
K873986 SCHIFF & CO. BETA-HCG ASSAY 02/02/1988
K941983 SEALITE SCIENCES, INC. SEALITE SCIENCES INC. 08/18/1994
K883235 SYNBIOTICS CORP. RAPIDTEST-HCG (TM) 09/30/1988
K893953 TOTEM DIAGNOSTICS, INC. ABSOLUTE(TM)-HCG URINE PREGNANCY TEST 08/15/1989
K880678 VENTREX LABORATORIES, INC. MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY 04/05/1988
K013678 VICTORCH MEDITEK, INC. VICTORCH MEDITEK'S HCG TEST CARD 12/27/2001
K882896 WAMPOLE LABORATORIES ONE-STEP HCG 10/31/1988


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