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 |
| K230937 | Abbott Laboratories | Alinity i Total ▀-hCG Reagent Kit, GLP systems Track | 06/05/2023 |
| K230790 | Abbott Laboratories | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series | 05/19/2023 |
| 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 |
| 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 |
| K961351 | BAYER CORP. | HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD | 06/03/1996 |
| K221990 | Beckman Coulter, Inc | Access Total ▀hCG (5th IS) | 12/27/2022 |
| 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 |
| K961487 | BOEHRINGER MANNHEIM CORP. | ELECSYS HCG ASSAY | 06/12/1996 |
| 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 |
| 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 |
| K131037 | DIASORIN, INC. | LIAISON XL HCG | 09/06/2013 |
| K163418 | Diazyme Laboratories | Diazyme DZ-Lite Total beta-hCG Test System | 08/18/2017 |
| K212221 | Diazyme Laboratories Inc. | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer | 12/13/2021 |
| 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 |
| K991515 | INBIOS INTL., INC. | INSURE PREGNANCY TEST | 05/28/1999 |
| 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 |
| 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 |
| K063720 | ORTHO-CLINICAL DIAGNOSTICS | VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS | 04/09/2007 |
| 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 |
| K203227 | ROCHE DIAGNOSTICS | Elecsys HCG STAT | 08/18/2021 |
| K003178 | ROCHE DIAGNOSTICS CORP. | ELECSYS HCG AND BETA TEST SYSTEM | 12/14/2000 |
| K002148 | ROCHE DIAGNOSTICS CORP. | ELECSYS HCG TEST SYSTEM | 08/22/2000 |
| K192547 | Shenzhen New Industries Biomedical Engineering Co., Ltd | MAGLUMI 2000 HCG/▀-HCG | 01/17/2020 |
| K192790 | Siemens Healthcare Diagnostics Inc. | Atellica IM Total hCG (ThCG) | 10/30/2019 |
| K200210 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur« Total hCG assay | 07/13/2021 |
| K013678 | VICTORCH MEDITEK, INC. | VICTORCH MEDITEK'S HCG TEST CARD | 12/27/2001 |
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