FDA 510(k) Applications for Medical Device Product Code "JHI"
(Radioimmunoassay, Human Chorionic Gonadotropin)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K965116 | ABBOTT LABORATORIES | ABBOTT TESTPACK PLUS HCG COMBO WITH OBC | 02/20/1997 |
| K031048 | ACCESS BIO INCORPORATE | CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST | 06/16/2003 |
| K980736 | ACON LABORATORIES CO. | ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST | 04/16/1998 |
| K993065 | ACON LABORATORIES, INC. | ACON COMBO PREGNANCY | 10/08/1999 |
| K993317 | ACON LABORATORIES, INC. | ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE) | 12/01/1999 |
| K993203 | ACON LABORATORIES, INC. | ACON ONE STEP PREGNANCY TEST STRIP (URINE) | 12/01/1999 |
| K041946 | ACON LABORATORIES, INC. | ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE | 08/16/2004 |
| K994227 | ADVANTAGE DIAGNOSTICS CORP. | ADVANTAGE HCG TEST (URINE/SERUM) | 02/03/2000 |
| K984080 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST | 02/16/1999 |
| K984077 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW PREGNANCY COMBO TEST | 02/16/1999 |
| K984079 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST | 02/16/1999 |
| K984076 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW PREGNANCY URINE TEST | 02/16/1999 |
| K021386 | ALIDEX, INC. | POLY STAT HCG DIPSTICK TEST | 08/05/2002 |
| K030430 | ALIDEX, INC. | POLY STAT SERUM/URINE HCG TEST | 04/18/2003 |
| K061257 | AMERITEK USA, INC. | DBEST HCG PANEL TEST KIT | 05/04/2007 |
| K001215 | AMERITEK, INC. | DBEST HCG 2 IU/ML TEST KIT | 06/22/2000 |
| K973957 | AMERITEK, INC. | DBEST ONE-STEP HCG SERUM/URINE TEST | 12/17/1997 |
| K070921 | APPLIED DNA TECHNOLOGIES, INC. | BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG | 06/29/2007 |
| K071030 | APPLIED DNA TECHNOLOGIES, INC. | BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC | 06/29/2007 |
| K152768 | ASSURE TECH. CO., LTD. | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip | 02/24/2016 |
| K964574 | ATHENA MEDICAL CORP. | AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST | 01/21/1997 |
| K023944 | BAYER CORP. | BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST | 02/11/2003 |
| K971209 | BAYER CORP. | CLINITEK HCG TEST STRIPS | 04/04/1997 |
| K032563 | BAYER HEALTHCARE, LLC | CLINITEST HCG PREGNANCY TEST | 12/23/2003 |
| K023480 | BECKMAN COULTER, INC. | ACCESS TOTAL BHCG | 12/20/2002 |
| K980173 | BECKMAN INSTRUMENTS, INC. | ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 | 03/18/1998 |
| K991741 | BIOCHECK, INC. | BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 | 07/22/1999 |
| K954065 | BIOCHEM IMMUNOSYSTEMS (U.S.), INC. | BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT | 07/10/1996 |
| K992915 | BIOMEDICAL PRODUCTS CORP. | ONE-STEP DOUBLE-CHEK PREGNANCY TEST | 11/18/1999 |
| K003856 | BIOMERICA, INC. | EZ-HCG URINE(PREGNANCY TEST) | 02/21/2001 |
| K012559 | BION DIAGNOSTIC SCIENCES | POLY STAT HCG TEST | 10/16/2001 |
| K960992 | BIONIKE LABORATORIES, INC. | BIONIKE A/Q PREGNANCY TEST | 04/25/1996 |
| K013194 | BIOTECH ATLANTIC, INC. | UNIMARK HCG COMBO PREGNANCY TEST | 10/10/2001 |
| K955266 | BOEHRINGER MANNHEIM ITALIA SPA | ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT | 02/29/1996 |
| K992397 | CENOGENICS CORP. | ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE | 08/26/1999 |
| K011550 | Chembio Diagnostic Systems, Inc. | HCG STAT PAK ULTRA-FAST | 08/14/2001 |
| K123844 | CHEMTRON BIOTECH, INC. | CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST | 05/30/2013 |
| K020128 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. | ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 | 03/01/2002 |
| K961911 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. | DSL ACTIVE I-HCG ELISA | 06/28/1996 |
| K960357 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. | DSL ACTIVE I-HCG IRMA | 05/07/1996 |
| K970424 | EXCEL SCIENTIFIC, INC. | EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST | 03/06/1997 |
| K963231 | EXCEL SCIENTIFIC, INC. | EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST | 12/04/1996 |
| K971122 | GENIX BIOTEK, INC. | ACCULINE PREGNANCY TEST | 04/25/1997 |
| K964633 | GENIX BIOTEK, INC. | ACCUPACK PREGNANCY TEST | 02/20/1997 |
| K023544 | GENZYME CORP. | GENZYME CONTRAST II HCG URINE/SERUM TEST | 01/16/2003 |
| K964155 | GENZYME DIAGNOSTICS | CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST | 11/25/1996 |
| K964156 | GENZYME DIAGNOSTICS | CONTRAST STRIP HCG | 11/25/1996 |
| K043385 | GENZYME DIAGNOSTICS | OSOM HCG COMBO TEST | 04/12/2005 |
| K981165 | GERMAINE LABORATORIES, INC. | AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST | 04/16/1998 |
| K980531 | GERMAINE LABORATORIES, INC. | AIMSTEP PREGNANCY | 03/06/1998 |
| K203272 | Hangzhou AllTest Biotech Co., Ltd | Alltest Pregnancy Rapid Combo Test Cassette | 01/31/2022 |
| K041728 | IMMUNOSTICS, INC. | HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE | 08/11/2004 |
| K992695 | INBIOS INTL., INC. | INSURE PRO TEST | 10/18/1999 |
| K050741 | IND DIAGNOSTIC INC. | IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT | 05/16/2005 |
| K052694 | IND DIAGNOSTIC INC. | ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. | 12/16/2005 |
| K062361 | INNOVACON, INC. | INNOVACON HCG UKTRA TEST DEVICE | 10/23/2006 |
| K963132 | INTERNATIONAL NEWTECH DEVELOPMENT, INC. | MINI STRIP/SERUM HCG | 11/18/1996 |
| K974060 | INTERNATIONAL NEWTECH DEVELOPMENT, INC. | MINISTRIP/ SERUM AND URINE COMBO HCG TEST | 04/09/1998 |
| K974009 | INTERNATIONAL NEWTECH DEVELOPMENT, INC. | PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG | 03/13/1998 |
| K963133 | INTERNATIONAL NEWTECH DEVELOPMENT, INC. | PS-UNIT CASSETTE/SERUM HCG | 11/18/1996 |
| K130456 | JAMES NGUYEN | WUNDER PREGNANCY TEST | 04/08/2014 |
| K031445 | MAINLINE TECHNOLOGY, INC. | MAINLINE MAXIE HCG URINE PREGNANCY TEST | 07/01/2003 |
| K112315 | NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD | HOME PREGNANCY TEST | 04/23/2012 |
| K020968 | PAN PROBE BIOTECH, INC. | LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD | 07/15/2002 |
| K991095 | PHAMATECH | QUICKCARD HCG COMBO TEST, MODEL #9014 | 04/28/1999 |
| K980896 | PHAMATECH | QUICKCARD PRO HCG TEST, MODEL 9008 | 04/02/1998 |
| K974615 | PHAMATECH | QUICKSTICK PRO HCG TEST | 01/26/1998 |
| K112101 | POLYMED THERAPEUTICS, INC | FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS | 07/17/2012 |
| K132834 | POLYMED THERAPEUTICS, INC | FASTEP S10 HCG SERUM/URINE COMBO TEST | 01/09/2014 |
| K981443 | PRINCETON BIOMEDITECH CORP. | BIOSIGN HCG I - ONE STEP PREGNANCY TEST | 06/25/1998 |
| K981444 | PRINCETON BIOMEDITECH CORP. | BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP | 07/22/1998 |
| K050955 | PRINCETON BIOMEDITECH CORP. | LIFESIGN DXPRESS, MODEL LSR2000 | 01/23/2006 |
| K020439 | PRINCETON BIOMEDITECH CORP. | STATUS HCG SERUM/URINE | 05/23/2002 |
| K072264 | Qualigen, Inc. | FASTPACK HCG IMMUNOASSAY | 12/06/2007 |
| K973858 | QUIDEL CORP. | CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO | 11/26/1997 |
| K972748 | QUIDEL CORP. | CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE | 08/29/1997 |
| K020801 | QUIDEL CORP. | QUICKVUE ONE-STEP HCG-COMBO | 05/17/2002 |
| K973841 | QUIDEL CORP. | QUICKVUE ONE-STEP HCG-COMBO | 12/01/1997 |
| K972742 | QUIDEL CORP. | QUICKVUE ONE-STEP HCG-URINE | 08/29/1997 |
| K020799 | QUIDEL CORP. | QUICKVUE ONE-STEP HCG-URINE | 05/17/2002 |
| K974052 | QUIDEL CORP. | QUICKVUE SEMI-Q HCG-COMBO | 12/19/1997 |
| K131166 | QUIDEL CORP. | SOFIA(R) HCG FIA | 08/02/2013 |
| K102175 | QUIDEL CORPORATION | RAPIDVUE HCG TEST | 08/25/2010 |
| K981770 | RAPID DIAGNOSTICS, INC. | RAPIDHCG PREGNANCY TEST | 06/05/1998 |
| K990684 | SA SCIENTIFIC, INC. | MODIFICATION OF SAS SERUM/URINE HCG | 05/10/1999 |
| K022683 | SA SCIENTIFIC, INC. | SAS BLOOD/SERUM/URINE/URINE HCG | 12/16/2002 |
| K964995 | SA SCIENTIFIC, INC. | SAS ONE-STEP PREGNANCY | 01/21/1997 |
| K990741 | SA SCIENTIFIC, INC. | SAS ONE-STEP PREGNANCY | 05/10/1999 |
| K020438 | SA SCIENTIFIC, INC. | SAS VALUE HCG | 03/08/2002 |
| K010593 | SA SCIENTIFIC, INC. | SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT | 04/05/2001 |
| K010522 | SA SCIENTIFIC, INC. | SUREVUE URINE HCG | 07/31/2001 |
| K980205 | SAN DIEGO BIOTECH | SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST | 02/12/1998 |
| K974851 | SAN DIEGO BIOTECH | SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST | 01/22/1998 |
| K965253 | SASCIE | SAS PREGNANCY STRIP | 02/18/1997 |
| K965250 | SASCIE | SAS SERUM/URINE HCG | 02/18/1997 |
| K962906 | SCRIPPS LABORATORIES, INC. | SCRIPPS LABORATORIES HCG ONE-STEP | 08/23/1996 |
| K172322 | Siemens Healthcare Diagnostics Inc. | Atellica IM Total hCG (ThCG) | 03/29/2018 |
| K991067 | SIMEX MEDICAL, INC. | MODIFICATION OF: DAVIDSTRIP HCG | 04/27/1999 |
| K981512 | SKD, INC. A BECKMAN COULTER CO. | ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025 | 05/28/1998 |
| K020378 | STANBIO LABORATORY | QUPID PLUS E.R. | 06/21/2002 |
| K963408 | SUN BIOMEDICAL LABORATORIES, INC. | VISUALINE D HCG | 10/18/1996 |
| K955353 | TCPI, INC. | ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT | 03/19/1996 |
| K964461 | TECO DIAGNOSTICS | ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST | 02/11/1997 |
| K964536 | TECO DIAGNOSTICS | ONE-STEP DIPSTICK PREGNANCY TEST | 02/11/1997 |
| K964462 | TECO DIAGNOSTICS | ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST | 02/11/1997 |
| K172257 | True Diagnostics, Inc | 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) | 12/22/2017 |
| K993703 | UNIPATH LTD. | CLEARVIEW EASY HCG PREGNANCY TEST | 12/02/1999 |
| K981838 | UNOTECH DIAGNOSTICS, INC. | ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002 | 06/25/1998 |
| K032987 | UNOTECH DIAGNOSTICS, INC. | ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005 | 11/17/2003 |
| K971886 | UNOTECH DIAGNOSTICS, INC. | ACCUTEST HCG-URINE | 06/11/1997 |
| K013702 | VICTORCH MEDITEK, INC. | VICTORCH HCG TEST STRIP | 12/27/2001 |
| K051841 | W.H.P.M., INC. | WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST | 08/22/2005 |
| K012284 | W.H.P.M., INC. | WH ACCU TEST PREGNANCY TEST | 08/28/2001 |
| K973879 | WYNTEK DIAGNOSTICS, INC. | OSOM CARD HCG-URINE TEST | 11/04/1997 |
| K990578 | WYNTEK DIAGNOSTICS, INC. | OSOM CARD II HCG-URINE TEST, MODEL 102 | 03/09/1999 |
| K965227 | WYNTEK DIAGNOSTICS, INC. | OSOM CLASSIC HCG-URINE TEST (115) | 02/04/1997 |
| K974159 | WYNTEK DIAGNOSTICS, INC. | OSOM HCG-URINE TEST MODEL 101 | 12/24/1997 |
| K033297 | ZBX CORPORATION | ZAP HCG TEST, MODEL 8001 | 03/18/2004 |
| K023823 | ZER HITECH | EASYCUP | 05/22/2003 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
