Panels › Clinical Chemistry › Product code JHI · Class 2
Visual, Pregnancy Hcg, Prescription Use
Regulation 862.1155
1510(k)s in 12 months (376 all time)
4recalls in 12 months (47 all time)
34recalls that name a 510(k)
Top companies in JHI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 22, 2026 | K262299 | Instant-View® hCG Combo II Cassette Test Alfa Scientific Designs, Inc. | JHI |
| Aug 2, 2024 | K241919 | Innovita HCG Pregnancy Rapid Combo Test Innovita (Tangshan) Biological Technology Co., Ltd., CN | JHI |
| Jan 31, 2022 | K203272 | Alltest Pregnancy Rapid Combo Test Cassette Hangzhou AllTest Biotech Co., Ltd., CN | JHI |
| Mar 29, 2018 | K172322 | Atellica IM Total hCG (ThCG) Siemens Healthcare Diagnostics, Inc. | JHI |
| Dec 22, 2017 | K172257 | TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), Ver True Diagnostics, Inc. | JHI |
| Feb 24, 2016 | K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip Assure Tech. Co., Ltd., CN | JHI |
| Apr 8, 2014 | K130456 | WUNDER PREGNANCY TEST James Nguyen | JHI |
| Jan 9, 2014 | K132834 | FASTEP S10 HCG SERUM/URINE COMBO TEST Polymed Therapeutics, Inc. | JHI |
| Aug 2, 2013 | K131166 | SOFIA(R) HCG FIA Quidel Corp. | JHI |
| May 30, 2013 | K123844 | CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST Chemtron Biotech, Inc. | JHI |
| Jul 17, 2012 | K112101 | FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS Polymed Therapeutics, Inc. | JHI |
| Apr 23, 2012 | K112315 | HOME PREGNANCY TEST Newscen Coast Bio-Pharmaceutical Co., Ltd. | JHI |
| Aug 25, 2010 | K102175 | RAPIDVUE HCG TEST Quidel Corporation | JHI |
| Dec 6, 2007 | K072264 | FASTPACK HCG IMMUNOASSAY Qualigen, Inc. | JHI |
| Jun 29, 2007 | K071030 | BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC Applied Dna Technologies, Inc. | JHI |
| Jun 29, 2007 | K070921 | BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG Applied Dna Technologies, Inc. | JHI |
| May 4, 2007 | K061257 | DBEST HCG PANEL TEST KIT Ameritek USA, Inc. | JHI |
| Oct 23, 2006 | K062361 | INNOVACON HCG UKTRA TEST DEVICE Innovacon, Inc. | JHI |
| Jan 23, 2006 | K050955 | LIFESIGN DXPRESS, MODEL LSR2000 Princeton BioMeditech Corp. | JHI |
| Dec 16, 2005 | K052694 | ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. Ind Diagnostic, Inc., CA | JHI |
| Aug 22, 2005 | K051841 | WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST W.H.P.M., Inc. | JHI |
| May 16, 2005 | K050741 | IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT Ind Diagnostic, Inc., CA | JHI |
| Apr 12, 2005 | K043385 | OSOM HCG COMBO TEST Genzyme Diagnostics | JHI |
| Aug 16, 2004 | K041946 | ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE ACON Laboratories, Inc. | JHI |
| Aug 11, 2004 | K041728 | HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE Immunostics Inc., | JHI |
| Mar 18, 2004 | K033297 | ZAP HCG TEST, MODEL 8001 Zbx Corporation, CA | JHI |
| Dec 23, 2003 | K032563 | CLINITEST HCG PREGNANCY TEST Bayer Healthcare, LLC | JHI |
| Nov 17, 2003 | K032987 | ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005 Unotech Diagnostics, Inc. | JHI |
| Jul 1, 2003 | K031445 | MAINLINE MAXIE HCG URINE PREGNANCY TEST Mainline Technology, Inc. | JHI |
| Jun 16, 2003 | K031048 | CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST Access Bio Incorporate | JHI |
| May 22, 2003 | K023823 | EASYCUP Zer Hitech | JHI |
| Apr 18, 2003 | K030430 | POLY STAT SERUM/URINE HCG TEST Alidex, Inc. | JHI |
| Feb 11, 2003 | K023944 | BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST Bayer Corp. | JHI |
| Jan 16, 2003 | K023544 | GENZYME CONTRAST II HCG URINE/SERUM TEST Genzyme Corp. | JHI |
| Dec 20, 2002 | K023480 | ACCESS TOTAL BHCG Beckman Coulter, Inc. | JHI |
| Dec 16, 2002 | K022683 | SAS BLOOD/SERUM/URINE/URINE HCG Sa Scientific, Inc. | JHI |
| Aug 5, 2002 | K021386 | POLY STAT HCG DIPSTICK TEST Alidex, Inc. | JHI |
| Jul 15, 2002 | K020968 | LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD Pan Probe Biotech, Inc. | JHI |
| Jun 21, 2002 | K020378 | QUPID PLUS E.R. Stanbio Laboratory | JHI |
| May 23, 2002 | K020439 | STATUS HCG SERUM/URINE Princeton BioMeditech Corp. | JHI |
| May 17, 2002 | K020801 | QUICKVUE ONE-STEP HCG-COMBO Quidel Corp. | JHI |
| May 17, 2002 | K020799 | QUICKVUE ONE-STEP HCG-URINE Quidel Corp. | JHI |
| Mar 8, 2002 | K020438 | SAS VALUE HCG Sa Scientific, Inc. | JHI |
| Mar 1, 2002 | K020128 | ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 Diagnostic Systems Laboratories, Inc. | JHI |
| Dec 27, 2001 | K013702 | VICTORCH HCG TEST STRIP Victorch Meditek, Inc. | JHI |
| Oct 16, 2001 | K012559 | POLY STAT HCG TEST Bion Diagnostic Sciences | JHI |
| Oct 10, 2001 | K013194 | UNIMARK HCG COMBO PREGNANCY TEST Biotech Atlantic, Inc. | JHI |
| Aug 28, 2001 | K012284 | WH ACCU TEST PREGNANCY TEST W.H.P.M., Inc. | JHI |
| Aug 14, 2001 | K011550 | HCG STAT PAK ULTRA-FAST Chembio Diagnostic Systems, Inc. | JHI |
| Jul 31, 2001 | K010522 | SUREVUE URINE HCG Sa Scientific, Inc. | JHI |
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