FDA Product Code
FDA Product Code JHI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1155
510(k) Clearances — 376 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262299 | Instant-View® hCG Combo II Cassette Test | Alfa Scientific Designs, Inc. | 2026-09-22 | Traditional | PDF ↗ |
| K241919 | Innovita HCG Pregnancy Rapid Combo Test | Innovita (Tangshan) Biological Technology Co., Ltd. | 2024-08-02 | Traditional | PDF ↗ |
| K203272 | Alltest Pregnancy Rapid Combo Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2022-01-31 | Traditional | PDF ↗ |
| K172322 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | 2018-03-29 | Traditional | PDF ↗ |
| K172257 | 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) | True Diagnostics, Inc. | 2017-12-22 | Traditional | PDF ↗ |
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip | Assure Tech. Co., Ltd. | 2016-02-24 | Traditional | PDF ↗ |
| K130456 | WUNDER PREGNANCY TEST | James Nguyen | 2014-04-08 | Traditional | PDF ↗ |
| K132834 | FASTEP S10 HCG SERUM/URINE COMBO TEST | Polymed Therapeutics, Inc. | 2014-01-09 | Traditional | PDF ↗ |
| K131166 | SOFIA(R) HCG FIA | Quidel Corp. | 2013-08-02 | Traditional | PDF ↗ |
| K123844 | CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST | Chemtron Biotech, Inc. | 2013-05-30 | Traditional | PDF ↗ |
| K112101 | FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS | Polymed Therapeutics, Inc. | 2012-07-17 | Traditional | PDF ↗ |
| K112315 | HOME PREGNANCY TEST | Newscen Coast Bio-Pharmaceutical Co., Ltd. | 2012-04-23 | Traditional | PDF ↗ |
| K102175 | RAPIDVUE HCG TEST | Quidel Corporation | 2010-08-25 | Special | PDF ↗ |
| K072264 | FASTPACK HCG IMMUNOASSAY | Qualigen, Inc. | 2007-12-06 | Traditional | PDF ↗ |
| K071030 | BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC | Applied Dna Technologies, Inc. | 2007-06-29 | Traditional | PDF ↗ |
| K070921 | BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG | Applied Dna Technologies, Inc. | 2007-06-29 | Traditional | PDF ↗ |
| K061257 | DBEST HCG PANEL TEST KIT | Ameritek USA, Inc. | 2007-05-04 | Traditional | PDF ↗ |
| K062361 | INNOVACON HCG UKTRA TEST DEVICE | Innovacon, Inc. | 2006-10-23 | Traditional | PDF ↗ |
| K050955 | LIFESIGN DXPRESS, MODEL LSR2000 | Princeton BioMeditech Corp. | 2006-01-23 | Traditional | PDF ↗ |
| K052694 | ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. | Ind Diagnostic, Inc. | 2005-12-16 | Traditional | PDF ↗ |
| K051841 | WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST | W.H.P.M., Inc. | 2005-08-22 | Traditional | PDF ↗ |
| K050741 | IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT | Ind Diagnostic, Inc. | 2005-05-16 | Traditional | PDF ↗ |
| K043385 | OSOM HCG COMBO TEST | Genzyme Diagnostics | 2005-04-12 | Traditional | PDF ↗ |
| K041946 | ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE | ACON Laboratories, Inc. | 2004-08-16 | Traditional | PDF ↗ |
| K041728 | HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE | Immunostics Inc., | 2004-08-11 | Traditional | PDF ↗ |
| K033297 | ZAP HCG TEST, MODEL 8001 | Zbx Corporation | 2004-03-18 | Traditional | PDF ↗ |
| K032563 | CLINITEST HCG PREGNANCY TEST | Bayer Healthcare, LLC | 2003-12-23 | Traditional | PDF ↗ |
| K032987 | ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005 | Unotech Diagnostics, Inc. | 2003-11-17 | Traditional | PDF ↗ |
| K031445 | MAINLINE MAXIE HCG URINE PREGNANCY TEST | Mainline Technology, Inc. | 2003-07-01 | Traditional | PDF ↗ |
| K031048 | CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST | Access Bio Incorporate | 2003-06-16 | Traditional | PDF ↗ |
| K023823 | EASYCUP | Zer Hitech | 2003-05-22 | Traditional | PDF ↗ |
| K030430 | POLY STAT SERUM/URINE HCG TEST | Alidex, Inc. | 2003-04-18 | Traditional | PDF ↗ |
| K023944 | BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST | Bayer Corp. | 2003-02-11 | Abbreviated | PDF ↗ |
| K023544 | GENZYME CONTRAST II HCG URINE/SERUM TEST | Genzyme Corp. | 2003-01-16 | Traditional | PDF ↗ |
| K023480 | ACCESS TOTAL BHCG | Beckman Coulter, Inc. | 2002-12-20 | Traditional | PDF ↗ |
| K022683 | SAS BLOOD/SERUM/URINE/URINE HCG | Sa Scientific, Inc. | 2002-12-16 | Traditional | PDF ↗ |
| K021386 | POLY STAT HCG DIPSTICK TEST | Alidex, Inc. | 2002-08-05 | Traditional | PDF ↗ |
| K020968 | LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD | Pan Probe Biotech, Inc. | 2002-07-15 | Traditional | PDF ↗ |
| K020378 | QUPID PLUS E.R. | Stanbio Laboratory | 2002-06-21 | Traditional | PDF ↗ |
| K020439 | STATUS HCG SERUM/URINE | Princeton BioMeditech Corp. | 2002-05-23 | Traditional | PDF ↗ |
| K020801 | QUICKVUE ONE-STEP HCG-COMBO | Quidel Corp. | 2002-05-17 | Traditional | PDF ↗ |
| K020799 | QUICKVUE ONE-STEP HCG-URINE | Quidel Corp. | 2002-05-17 | Traditional | PDF ↗ |
| K020438 | SAS VALUE HCG | Sa Scientific, Inc. | 2002-03-08 | Abbreviated | PDF ↗ |
| K020128 | ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 | Diagnostic Systems Laboratories, Inc. | 2002-03-01 | Traditional | PDF ↗ |
| K013702 | VICTORCH HCG TEST STRIP | Victorch Meditek, Inc. | 2001-12-27 | Traditional | PDF ↗ |
| K012559 | POLY STAT HCG TEST | Bion Diagnostic Sciences | 2001-10-16 | Traditional | PDF ↗ |
| K013194 | UNIMARK HCG COMBO PREGNANCY TEST | Biotech Atlantic, Inc. | 2001-10-10 | Special | PDF ↗ |
| K012284 | WH ACCU TEST PREGNANCY TEST | W.H.P.M., Inc. | 2001-08-28 | Traditional | PDF ↗ |
| K011550 | HCG STAT PAK ULTRA-FAST | Chembio Diagnostic Systems, Inc. | 2001-08-14 | Special | PDF ↗ |
| K010522 | SUREVUE URINE HCG | Sa Scientific, Inc. | 2001-07-31 | Traditional | PDF ↗ |
| K010593 | SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT | Sa Scientific, Inc. | 2001-04-05 | Traditional | PDF ↗ |
| K003856 | EZ-HCG URINE(PREGNANCY TEST) | Biomerica, Inc. | 2001-02-21 | Traditional | PDF ↗ |
| K001215 | DBEST HCG 2 IU/ML TEST KIT | Ameritek, Inc. | 2000-06-22 | Abbreviated | PDF ↗ |
| K994227 | ADVANTAGE HCG TEST (URINE/SERUM) | Advantage Diagnostics Corp. | 2000-02-03 | Traditional | PDF ↗ |
| K993703 | CLEARVIEW EASY HCG PREGNANCY TEST | Unipath , Ltd. | 1999-12-02 | Traditional | PDF ↗ |
| K993317 | ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE) | ACON Laboratories, Inc. | 1999-12-01 | Traditional | PDF ↗ |
| K993203 | ACON ONE STEP PREGNANCY TEST STRIP (URINE) | ACON Laboratories, Inc. | 1999-12-01 | Traditional | PDF ↗ |
| K992915 | ONE-STEP DOUBLE-CHEK PREGNANCY TEST | Biomedical Products Corp. | 1999-11-18 | Traditional | PDF ↗ |
| K992695 | INSURE PRO TEST | Inbios Intl., Inc. | 1999-10-18 | Traditional | PDF ↗ |
| K993065 | ACON COMBO PREGNANCY | ACON Laboratories, Inc. | 1999-10-08 | Traditional | PDF ↗ |
| K992397 | ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE | Cenogenics Corp. | 1999-08-26 | Traditional | PDF ↗ |
| K991741 | BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 | Biocheck, Inc. | 1999-07-22 | Traditional | PDF ↗ |
| K990684 | MODIFICATION OF SAS SERUM/URINE HCG | Sa Scientific, Inc. | 1999-05-10 | Traditional | PDF ↗ |
| K990741 | SAS ONE-STEP PREGNANCY | Sa Scientific, Inc. | 1999-05-10 | Traditional | PDF ↗ |
| K991095 | QUICKCARD HCG COMBO TEST, MODEL #9014 | Phamatech | 1999-04-28 | Traditional | PDF ↗ |
| K991067 | MODIFICATION OF: DAVIDSTRIP HCG | Simex Medical, Inc. | 1999-04-27 | Traditional | PDF ↗ |
| K990578 | OSOM CARD II HCG-URINE TEST, MODEL 102 | Wyntek Diagnostics, Inc. | 1999-03-09 | Traditional | PDF ↗ |
| K984076 | INSTANT-VIEW PREGNANCY URINE TEST | Alfa Scientific Designs, Inc. | 1999-02-16 | Traditional | PDF ↗ |
| K984079 | INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST | Alfa Scientific Designs, Inc. | 1999-02-16 | Traditional | PDF ↗ |
| K984080 | INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST | Alfa Scientific Designs, Inc. | 1999-02-16 | Traditional | PDF ↗ |
| K984077 | INSTANT-VIEW PREGNANCY COMBO TEST | Alfa Scientific Designs, Inc. | 1999-02-16 | Traditional | PDF ↗ |
| K981444 | BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP | Princeton BioMeditech Corp. | 1998-07-22 | Traditional | PDF ↗ |
| K981443 | BIOSIGN HCG I - ONE STEP PREGNANCY TEST | Princeton BioMeditech Corp. | 1998-06-25 | Traditional | PDF ↗ |
| K981838 | ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002 | Unotech Diagnostics, Inc. | 1998-06-25 | Traditional | PDF ↗ |
| K981770 | RAPIDHCG PREGNANCY TEST | Rapid Diagnostics, Inc. | 1998-06-05 | Traditional | PDF ↗ |
| K981512 | ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025 | Skd, Inc. A Beckman Coulter Co. | 1998-05-28 | Traditional | PDF ↗ |
| K980736 | ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST | Acon Laboratories Co. | 1998-04-16 | Traditional | PDF ↗ |
| K981165 | AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST | Germaine Laboratories, Inc. | 1998-04-16 | Traditional | PDF ↗ |
| K974060 | MINISTRIP/ SERUM AND URINE COMBO HCG TEST | International Newtech Development, Inc. | 1998-04-09 | Traditional | PDF ↗ |
| K980896 | QUICKCARD PRO HCG TEST, MODEL 9008 | Phamatech | 1998-04-02 | Traditional | PDF ↗ |
| K980173 | ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 | Beckman Instruments, Inc. | 1998-03-18 | Traditional | PDF ↗ |
| K974009 | PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG | International Newtech Development, Inc. | 1998-03-13 | Traditional | PDF ↗ |
| K980531 | AIMSTEP PREGNANCY | Germaine Laboratories, Inc. | 1998-03-06 | Traditional | PDF ↗ |
| K980205 | SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST | San Diego Biotech | 1998-02-12 | Traditional | PDF ↗ |
| K974615 | QUICKSTICK PRO HCG TEST | Phamatech | 1998-01-26 | Traditional | PDF ↗ |
| K974851 | SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST | San Diego Biotech | 1998-01-22 | Traditional | PDF ↗ |
| K974159 | OSOM HCG-URINE TEST MODEL 101 | Wyntek Diagnostics, Inc. | 1997-12-24 | Traditional | PDF ↗ |
| K974052 | QUICKVUE SEMI-Q HCG-COMBO | Quidel Corp. | 1997-12-19 | Traditional | PDF ↗ |
| K973957 | DBEST ONE-STEP HCG SERUM/URINE TEST | Ameritek, Inc. | 1997-12-17 | Traditional | PDF ↗ |
| K973841 | QUICKVUE ONE-STEP HCG-COMBO | Quidel Corp. | 1997-12-01 | Traditional | PDF ↗ |
| K973858 | CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO | Quidel Corp. | 1997-11-26 | Traditional | PDF ↗ |
| K973879 | OSOM CARD HCG-URINE TEST | Wyntek Diagnostics, Inc. | 1997-11-04 | Traditional | PDF ↗ |
| K972748 | CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE | Quidel Corp. | 1997-08-29 | Traditional | PDF ↗ |
| K972742 | QUICKVUE ONE-STEP HCG-URINE | Quidel Corp. | 1997-08-29 | Traditional | PDF ↗ |
| K971886 | ACCUTEST HCG-URINE | Unotech Diagnostics, Inc. | 1997-06-11 | Traditional | PDF ↗ |
| K971122 | ACCULINE PREGNANCY TEST | Genix Biotek, Inc. | 1997-04-25 | Traditional | PDF ↗ |
| K971209 | CLINITEK HCG TEST STRIPS | Bayer Corp. | 1997-04-04 | Traditional | PDF ↗ |
| K970424 | EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST | Excel Scientific, Inc. | 1997-03-06 | Traditional | PDF ↗ |
| K964633 | ACCUPACK PREGNANCY TEST | Genix Biotek, Inc. | 1997-02-20 | Traditional | PDF ↗ |
| K965116 | ABBOTT TESTPACK PLUS HCG COMBO WITH OBC | Abbott Laboratories | 1997-02-20 | Traditional | PDF ↗ |
Product code JHI · Class II · Clinical Chemistry. Data: openFDA.