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 |
|---|---|---|---|
| Mar 25, 1993 | K930014 | PROCLINIC ONE-STEP DIPSTICK PREGNANCY TEST Vanguard Biomedical Corp. | JHI |
| Mar 19, 1993 | K925277 | CIBA CORNING ACS HCG IMMUNOASSAY Ciba Corning Diagnostics Corp. | JHI |
| Mar 18, 1993 | K926356 | PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG Becton Dickinson Advanced Diagnostics | JHI |
| Feb 17, 1993 | K926342 | VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY Syva Co. | JHI |
| Feb 8, 1993 | K926198 | ACCESS TOTAL BHCG ASSAY Bio-Rad Laboratories, Inc. | JHI |
| Feb 2, 1993 | K926204 | SAS ONE STEP PREGNANCY Sa Scientific, Inc. | JHI |
| Jan 13, 1993 | K925125 | PRO-STEP HCG Disease Detection International, Inc. | JHI |
| Dec 24, 1992 | K923925 | HCG STAT-PAK Chembio Diagnostic Systems, Inc. | JHI |
| Dec 3, 1992 | K925435 | QUICKVUE ONE-STEP HCG TEST Quidel Corp. | JHI |
| Nov 25, 1992 | K924259 | MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 Medix Biotech, Inc. | JHI |
| Oct 1, 1992 | K923376 | VISUAL HCG PREGNANCY TEST Tech-Co, Inc. | JHI |
| Sep 15, 1992 | K923030 | ANI BIOCARD HCG TEST Ani OY, CA | JHI |
| Sep 9, 1992 | K923123 | HCG PREGNANCY ONE STEP TEST STRIP Tcpi, Inc. | JHI |
| Aug 10, 1992 | K922697 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD E.I. Dupont DE Nemours & Co., Inc. | JHI |
| Jul 28, 1992 | K921302 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM Vitek Systems, Inc. | JHI |
| Jul 9, 1992 | K922290 | SINGLE-STEP PREGNANCY, HCG TEST American Medical Products, Inc. | JHI |
| May 7, 1992 | K921212 | MIRCO ELISA HPL TEST KIT Bio Clinic Co. | JHI |
| May 7, 1992 | K921211 | NOW PREGNANCY TEST KIT Bio Clinic Co. | JHI |
| Apr 7, 1992 | K920918 | TMB CHROMOGEN/SUBSTRATE REAGENT SET Bio Clinic Co. | JHI |
| Mar 23, 1992 | K920505 | AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR Eastman Kodak Company | JHI |
| Feb 14, 1992 | K920253 | MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | JHI |
| Jan 27, 1992 | K915701 | KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION Eastman Kodak Company | JHI |
| Dec 17, 1991 | K915197 | PRECISE TM HCG Becton Dickinson Advanced Diagnostics | JHI |
| Dec 16, 1991 | K915200 | PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA Becton Dickinson Advanced Diagnostics | JHI |
| Nov 13, 1991 | K914696 | MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011 Medix Biotech, Inc. | JHI |
| Oct 25, 1991 | K914240 | CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF Unipath , Ltd., GB | JHI |
| Oct 11, 1991 | K914303 | TARGET(TM)-HOG V-Tech, Inc. | JHI |
| Oct 11, 1991 | K914253 | PROCLINIC ONE STEP PREGNANCY TEST Vanguard Biomedical Corp. | JHI |
| Aug 16, 1991 | K913122 | DIRECTIGEN 1-2-3(TM) HCG TEST Quidel Corp. | JHI |
| Jul 19, 1991 | K911826 | IMMUNOCARD HCG ONE STEP (I-S) TEST KIT Disease Detection International, Inc. | JHI |
| Jul 1, 1991 | K912535 | IMX TOTAL B-HCG Abbott Laboratories | JHI |
| Jul 1, 1991 | K912534 | IMX HCG Abbott Laboratories | JHI |
| Jun 24, 1991 | K911047 | OBA(TM) SERUM HCG ASSAY Adeza Biomedical | JHI |
| May 15, 1991 | K905741 | CLEARVIEW HCG SERUM/URINE Unipath , Ltd., GB | JHI |
| Mar 21, 1991 | K910349 | IMMUNOCORP COATED TUBE IRMA HCG Immunocorp, CA | JHI |
| Feb 26, 1991 | K910420 | BIOCLONE'S ELEGANCE HCG ELISA KIT Bioclone Australia Pty , Ltd. | JHI |
| Oct 22, 1990 | K903937 | TARGET(TM) HOG ONE STEP V-Tech, Inc. | JHI |
| Oct 15, 1990 | K904016 | MAXI TEST Bhc Biotech , Ltd., CA | JHI |
| Oct 3, 1990 | K904123 | CIBA CORNING ACS HCG IMMUNOASSAY Ciba Corning Diagnostics Corp. | JHI |
| Sep 25, 1990 | K903219 | ABBOTT TESTPACK PLUS TM HCG-COMBO Abbott Laboratories | JHI |
| Aug 9, 1990 | K902720 | AFFINITY HCG TEST SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | JHI |
| Aug 9, 1990 | K902681 | EZ-SCREEN:HCG Environmental Diagnostics, Inc. | JHI |
| Jun 28, 1990 | K902136 | KODAK SURECELL(TM) HCG-URINE TEST KIT Eastman Kodak Company | JHI |
| Jun 26, 1990 | K901935 | OPUS (TM) HCG Pb Diagnostic Systems, Inc. | JHI |
| May 4, 1990 | K901011 | BIOSIGN HCG-ONE STEP PREGNANCY TEST Princeton Biomedix | JHI |
| May 1, 1990 | K901484 | LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC London Diagnostics, Inc. | JHI |
| Apr 18, 1990 | K900327 | IMX HCG (LIST #03A63) Abbott Laboratories | JHI |
| Mar 29, 1990 | K901045 | HCG SOLID PHASE COMPONENT SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | JHI |
| Feb 16, 1990 | K896587 | MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | JHI |
| Feb 8, 1990 | K896901 | ENZYMUN TEST R HCG Boehringer Mannheim Corp. | JHI |
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