| Innovita HCG Pregnancy Rapid Combo Test (K241919) | Innovita (Tangshan) Biological Technology Co., Ltd. | 2024-08-02 |
| Alltest Pregnancy Rapid Combo Test Cassette (K203272) | Hangzhou AllTest Biotech Co., Ltd. | 2022-01-31 |
| Atellica IM Total hCG (ThCG) (K172322) | Siemens Healthcare Diagnostics, Inc. | 2018-03-29 |
| 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) (K172257) | True Diagnostics, Inc. | 2017-12-22 |
| Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip (K152768) | Assure Tech. Co., Ltd. | 2016-02-24 |
| WUNDER PREGNANCY TEST (K130456) | James Nguyen | 2014-04-08 |
| FASTEP S10 HCG SERUM/URINE COMBO TEST (K132834) | Polymed Therapeutics, Inc. | 2014-01-09 |
| SOFIA(R) HCG FIA (K131166) | Quidel Corp. | 2013-08-02 |
| CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST (K123844) | Chemtron Biotech, Inc. | 2013-05-30 |
| FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (K112101) | Polymed Therapeutics, Inc. | 2012-07-17 |
| HOME PREGNANCY TEST (K112315) | Newscen Coast Bio-Pharmaceutical Co., Ltd. | 2012-04-23 |
| RAPIDVUE HCG TEST (K102175) | Quidel Corporation | 2010-08-25 |
| FASTPACK HCG IMMUNOASSAY (K072264) | Qualigen, Inc. | 2007-12-06 |
| BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC (K071030) | Applied Dna Technologies, Inc. | 2007-06-29 |
| BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG (K070921) | Applied Dna Technologies, Inc. | 2007-06-29 |
| DBEST HCG PANEL TEST KIT (K061257) | Ameritek USA, Inc. | 2007-05-04 |
| INNOVACON HCG UKTRA TEST DEVICE (K062361) | Innovacon, Inc. | 2006-10-23 |
| LIFESIGN DXPRESS, MODEL LSR2000 (K050955) | Princeton BioMeditech Corp. | 2006-01-23 |
| ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. (K052694) | Ind Diagnostic, Inc. | 2005-12-16 |
| WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST (K051841) | W.H.P.M., Inc. | 2005-08-22 |
| IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT (K050741) | Ind Diagnostic, Inc. | 2005-05-16 |
| OSOM HCG COMBO TEST (K043385) | Genzyme Diagnostics | 2005-04-12 |
| ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE (K041946) | ACON Laboratories, Inc. | 2004-08-16 |
| HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE (K041728) | Immunostics Inc., | 2004-08-11 |
| ZAP HCG TEST, MODEL 8001 (K033297) | Zbx Corporation | 2004-03-18 |
| CLINITEST HCG PREGNANCY TEST (K032563) | Bayer Healthcare, LLC | 2003-12-23 |
| ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005 (K032987) | Unotech Diagnostics, Inc. | 2003-11-17 |
| MAINLINE MAXIE HCG URINE PREGNANCY TEST (K031445) | Mainline Technology, Inc. | 2003-07-01 |
| CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST (K031048) | Access Bio Incorporate | 2003-06-16 |
| EASYCUP (K023823) | Zer Hitech | 2003-05-22 |
| POLY STAT SERUM/URINE HCG TEST (K030430) | Alidex, Inc. | 2003-04-18 |
| BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST (K023944) | Bayer Corp. | 2003-02-11 |
| GENZYME CONTRAST II HCG URINE/SERUM TEST (K023544) | Genzyme Corp. | 2003-01-16 |
| ACCESS TOTAL BHCG (K023480) | Beckman Coulter, Inc. | 2002-12-20 |
| SAS BLOOD/SERUM/URINE/URINE HCG (K022683) | Sa Scientific, Inc. | 2002-12-16 |
| POLY STAT HCG DIPSTICK TEST (K021386) | Alidex, Inc. | 2002-08-05 |
| LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD (K020968) | Pan Probe Biotech, Inc. | 2002-07-15 |
| QUPID PLUS E.R. (K020378) | Stanbio Laboratory | 2002-06-21 |
| STATUS HCG SERUM/URINE (K020439) | Princeton BioMeditech Corp. | 2002-05-23 |
| QUICKVUE ONE-STEP HCG-COMBO (K020801) | Quidel Corp. | 2002-05-17 |
| QUICKVUE ONE-STEP HCG-URINE (K020799) | Quidel Corp. | 2002-05-17 |
| SAS VALUE HCG (K020438) | Sa Scientific, Inc. | 2002-03-08 |
| ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 (K020128) | Diagnostic Systems Laboratories, Inc. | 2002-03-01 |
| VICTORCH HCG TEST STRIP (K013702) | Victorch Meditek, Inc. | 2001-12-27 |
| POLY STAT HCG TEST (K012559) | Bion Diagnostic Sciences | 2001-10-16 |
| UNIMARK HCG COMBO PREGNANCY TEST (K013194) | Biotech Atlantic, Inc. | 2001-10-10 |
| WH ACCU TEST PREGNANCY TEST (K012284) | W.H.P.M., Inc. | 2001-08-28 |
| HCG STAT PAK ULTRA-FAST (K011550) | Chembio Diagnostic Systems, Inc. | 2001-08-14 |
| SUREVUE URINE HCG (K010522) | Sa Scientific, Inc. | 2001-07-31 |
| SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT (K010593) | Sa Scientific, Inc. | 2001-04-05 |
| EZ-HCG URINE(PREGNANCY TEST) (K003856) | Biomerica, Inc. | 2001-02-21 |
| DBEST HCG 2 IU/ML TEST KIT (K001215) | Ameritek, Inc. | 2000-06-22 |
| ADVANTAGE HCG TEST (URINE/SERUM) (K994227) | Advantage Diagnostics Corp. | 2000-02-03 |
| CLEARVIEW EASY HCG PREGNANCY TEST (K993703) | Unipath , Ltd. | 1999-12-02 |
| ACON ONE STEP PREGNANCY TEST STRIP (URINE) (K993203) | ACON Laboratories, Inc. | 1999-12-01 |
| ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE) (K993317) | ACON Laboratories, Inc. | 1999-12-01 |
| ONE-STEP DOUBLE-CHEK PREGNANCY TEST (K992915) | Biomedical Products Corp. | 1999-11-18 |
| INSURE PRO TEST (K992695) | Inbios Intl., Inc. | 1999-10-18 |
| ACON COMBO PREGNANCY (K993065) | ACON Laboratories, Inc. | 1999-10-08 |
| ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE (K992397) | Cenogenics Corp. | 1999-08-26 |
| BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 (K991741) | Biocheck, Inc. | 1999-07-22 |
| SAS ONE-STEP PREGNANCY (K990741) | Sa Scientific, Inc. | 1999-05-10 |
| MODIFICATION OF SAS SERUM/URINE HCG (K990684) | Sa Scientific, Inc. | 1999-05-10 |
| QUICKCARD HCG COMBO TEST, MODEL #9014 (K991095) | Phamatech | 1999-04-28 |
| MODIFICATION OF: DAVIDSTRIP HCG (K991067) | Simex Medical, Inc. | 1999-04-27 |
| OSOM CARD II HCG-URINE TEST, MODEL 102 (K990578) | Wyntek Diagnostics, Inc. | 1999-03-09 |
| INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST (K984079) | Alfa Scientific Designs, Inc. | 1999-02-16 |
| INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST (K984080) | Alfa Scientific Designs, Inc. | 1999-02-16 |
| INSTANT-VIEW PREGNANCY COMBO TEST (K984077) | Alfa Scientific Designs, Inc. | 1999-02-16 |
| INSTANT-VIEW PREGNANCY URINE TEST (K984076) | Alfa Scientific Designs, Inc. | 1999-02-16 |
| BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP (K981444) | Princeton BioMeditech Corp. | 1998-07-22 |
| BIOSIGN HCG I - ONE STEP PREGNANCY TEST (K981443) | Princeton BioMeditech Corp. | 1998-06-25 |
| ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002 (K981838) | Unotech Diagnostics, Inc. | 1998-06-25 |
| RAPIDHCG PREGNANCY TEST (K981770) | Rapid Diagnostics, Inc. | 1998-06-05 |
| ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025 (K981512) | Skd, Inc. A Beckman Coulter Co. | 1998-05-28 |
| AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST (K981165) | Germaine Laboratories, Inc. | 1998-04-16 |
| ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST (K980736) | Acon Laboratories Co. | 1998-04-16 |
| MINISTRIP/ SERUM AND URINE COMBO HCG TEST (K974060) | International Newtech Development, Inc. | 1998-04-09 |
| QUICKCARD PRO HCG TEST, MODEL 9008 (K980896) | Phamatech | 1998-04-02 |
| ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 (K980173) | Beckman Instruments, Inc. | 1998-03-18 |
| PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG (K974009) | International Newtech Development, Inc. | 1998-03-13 |
| AIMSTEP PREGNANCY (K980531) | Germaine Laboratories, Inc. | 1998-03-06 |
| SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST (K980205) | San Diego Biotech | 1998-02-12 |
| QUICKSTICK PRO HCG TEST (K974615) | Phamatech | 1998-01-26 |
| SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST (K974851) | San Diego Biotech | 1998-01-22 |
| OSOM HCG-URINE TEST MODEL 101 (K974159) | Wyntek Diagnostics, Inc. | 1997-12-24 |
| QUICKVUE SEMI-Q HCG-COMBO (K974052) | Quidel Corp. | 1997-12-19 |
| DBEST ONE-STEP HCG SERUM/URINE TEST (K973957) | Ameritek, Inc. | 1997-12-17 |
| QUICKVUE ONE-STEP HCG-COMBO (K973841) | Quidel Corp. | 1997-12-01 |
| CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO (K973858) | Quidel Corp. | 1997-11-26 |
| OSOM CARD HCG-URINE TEST (K973879) | Wyntek Diagnostics, Inc. | 1997-11-04 |
| QUICKVUE ONE-STEP HCG-URINE (K972742) | Quidel Corp. | 1997-08-29 |
| CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE (K972748) | Quidel Corp. | 1997-08-29 |
| ACCUTEST HCG-URINE (K971886) | Unotech Diagnostics, Inc. | 1997-06-11 |
| ACCULINE PREGNANCY TEST (K971122) | Genix Biotek, Inc. | 1997-04-25 |
| CLINITEK HCG TEST STRIPS (K971209) | Bayer Corp. | 1997-04-04 |
| EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST (K970424) | Excel Scientific, Inc. | 1997-03-06 |
| ACCUPACK PREGNANCY TEST (K964633) | Genix Biotek, Inc. | 1997-02-20 |
| ABBOTT TESTPACK PLUS HCG COMBO WITH OBC (K965116) | Abbott Laboratories | 1997-02-20 |
| SAS PREGNANCY STRIP (K965253) | Sascie | 1997-02-18 |