| VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (K233581) | Ortho Clinical Diagnostics | 2024-05-08 |
| iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (K223690) | Shenzhen Yhlo Biotech Co., Ltd. | 2023-12-11 |
| Alinity i Total ß-hCG Reagent Kit, GLP systems Track (K230937) | Abbott Laboratories | 2023-06-05 |
| Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series (K230790) | Abbott Laboratories | 2023-05-19 |
| Access Total ßhCG (5th IS) (K221990) | Beckman Coulter, Inc. | 2022-12-27 |
| Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer (K212221) | Diazyme Laboratories, Inc. | 2021-12-13 |
| Elecsys HCG STAT (K203227) | Roche Diagnostics | 2021-08-18 |
| ADVIA Centaur® Total hCG assay (K200210) | Siemens Healthcare Diagnostics, Inc. | 2021-07-13 |
| MAGLUMI 2000 HCG/ß-HCG (K192547) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2020-01-17 |
| Atellica IM Total hCG (ThCG) (K192790) | Siemens Healthcare Diagnostics, Inc. | 2019-10-30 |
| Alinity i Total ß-hCG Reagent Kit, Alinity i System (K170317) | Abbott Laboratories | 2017-10-23 |
| Diazyme DZ-Lite Total beta-hCG Test System (K163418) | Diazyme Laboratories | 2017-08-18 |
| i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials (K133002) | Abbott Point of Care, Inc. | 2015-04-16 |
| ACCESS TOTAL BHCG (5TH IS) (K130020) | Beckman Coulter, Inc. | 2013-10-01 |
| LIAISON XL HCG (K131037) | DiaSorin, Inc. | 2013-09-06 |
| ONE STEP HCG URINE/SERUM TEST (K072500) | Guangzhou Wondfo Biotech Co., Ltd. | 2009-04-21 |
| OLYMPUS TOTAL BHCG TEST SYSTEN (K080094) | Olympus Life Science Research Europa GmbH (Europa) | 2008-09-03 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS (K063720) | Ortho-Clinical Diagnostics | 2007-04-09 |
| DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 (K063754) | Dade Behring, Inc. | 2007-02-23 |
| STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK (K060548) | Dade Behring, Inc. | 2006-04-06 |
| NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY (K042676) | Nichols Institute Diagnostics | 2004-12-17 |
| IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (K033234) | Diagnostic Products Corp. | 2003-12-12 |
| CARESTART HCG ONE-STEP PREGNANCY TEST (K031052) | Access Bio Incorporate | 2003-06-13 |
| AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK) (K022680) | Azog, Inc. | 2002-11-01 |
| AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE) (K022681) | Azog, Inc. | 2002-11-01 |
| AIMSTEP PREGNANCY (K013857) | Germaine Laboratories, Inc. | 2002-01-22 |
| VICTORCH MEDITEK'S HCG TEST CARD (K013678) | Victorch Meditek, Inc. | 2001-12-27 |
| STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD (K003696) | Dade Behring, Inc. | 2001-01-25 |
| ELECSYS HCG AND BETA TEST SYSTEM (K003178) | Roche Diagnostics Corp. | 2000-12-14 |
| ELECSYS HCG TEST SYSTEM (K002148) | Roche Diagnostics Corp. | 2000-08-22 |
| ABSOLUTE HCG PREGNANCY TEST (K000844) | Mizuho USA, Inc. | 2000-06-16 |
| IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 (K994085) | Diagnostic Products Corp. | 2000-01-28 |
| DRX QT. HCG (K991532) | Metrika, Inc. | 1999-09-17 |
| INSURE PREGNANCY TEST (K991515) | Inbios Intl., Inc. | 1999-05-28 |
| IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6 (K990222) | Diagnostic Products Corp. | 1999-02-26 |
| ABBOTT ARCHEITECT TOTAL B-HCG (K983424) | Abbott Laboratories | 1998-12-01 |
| AIMSTICK PBD PREGNANCY (K974368) | Germaine Laboratories, Inc. | 1998-01-02 |
| AIMSTICK PBD COMBO PREGNANCY (K974512) | Germaine Laboratories, Inc. | 1998-01-02 |
| BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST (K974425) | Princeton BioMeditech Corp. | 1997-12-24 |
| MIDSTREAM HOME REGNANCY TEST (K973825) | Germaine Laboratories, Inc. | 1997-12-19 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075) (K970894) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-04-14 |
| HUMAN CHORIONIC GONADOTROPIN METHOD (K970387) | Dade Chemistry Systems, Inc. | 1997-03-10 |
| BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS (K961792) | Biocircuits Corp. | 1996-08-21 |
| ELECSYS HCG ASSAY (K961487) | Boehringer Mannheim Corp. | 1996-06-12 |
| HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD (K961351) | Bayer Corp. | 1996-06-03 |
| ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT (K955707) | Excel Scientific, Inc. | 1996-05-02 |
| AMERLITE HCG-60 ASSAY (K952283) | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-17 |
| AURAFLEX HCG (K945331) | Organon Teknika Corp. | 1995-03-20 |
| BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST (K950307) | Princeton BioMeditech Corp. | 1995-03-01 |
| SEALITE SCIENCES INC. (K941983) | Sealite Sciences, Inc. | 1994-08-18 |
| UNISTEP HCG PREGNANCY TEST STRIP (K941090) | Biotech Atlantic, Inc. | 1994-06-02 |
| SAS(TM) SERUM/URINE HCG (K932409) | Sa Scientific, Inc. | 1993-06-29 |
| STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY (K922073) | Baxter Diagnostics, Inc. | 1992-10-19 |
| STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY (K913236) | Baxter Healthcare Corp | 1991-08-16 |
| IMMULITE(TM) HCG (K911796) | Cirrus Diagnostics, Inc. | 1991-06-20 |
| SINGLE AND DUAL BAND DIPSTICK HCG TEST (K893873) | Ampcor, Inc. | 1989-08-21 |
| ABSOLUTE(TM)-HCG URINE PREGNANCY TEST (K893953) | Totem Diagnostics, Inc. | 1989-08-15 |
| STATUS HCG FLUOROMETRIC ENZYME (K893577) | Baxter Healthcare Corp | 1989-08-03 |
| BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST (K892654) | Princeton Biomedix | 1989-06-19 |
| VIS-DISK HCG (EIA) JPL-041M (K891096) | Leeco Diagnostics, Inc. | 1989-06-16 |
| VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M (K891095) | Leeco Diagnostics, Inc. | 1989-06-16 |
| SERUM HCG MICROASSAY (K884430) | Diamedix Corp. | 1988-12-09 |
| IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40 (K883148) | Diagnostic Chemicals, Ltd. (Usa) | 1988-12-05 |
| RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO (K884207) | Abbott Laboratories | 1988-12-02 |
| HYGEIA URINE PREGNANCY TEST (K882192) | Hygeia Sciences | 1988-11-10 |
| ONE-STEP HCG (K882896) | Wampole Laboratories | 1988-10-31 |
| MODIFIED BETA QUIK STAT EIA KIT (K882895) | Pacific Biotech, Inc. | 1988-10-12 |
| RAPIDTEST-HCG (TM) (K883235) | Synbiotics Corp. | 1988-09-30 |
| MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY (K880678) | Ventrex Laboratories, Inc. | 1988-04-05 |
| BETA-HCG ASSAY (K873986) | Schiff & Co. | 1988-02-02 |
| HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013 (K873872) | Medix Biotech, Inc. | 1987-10-28 |
| ENZYMUN-TEST HCG (K862108) | Boehringer Mannheim Corp. | 1986-08-19 |