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 |
|---|---|---|---|
| Dec 19, 1989 | K894175 | SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY Serono-Baker Diagnostics, Inc. | JHI |
| Dec 1, 1989 | K895912 | IMMUNOCARD HCG II-S TEST KIT Disease Detection International, Inc. | JHI |
| Dec 1, 1989 | K895809 | MILENIA(TM) HCG (MKCG1,5) Diagnostic Products Corp. | JHI |
| Nov 13, 1989 | K895390 | CARDS O.S. (TM) HCG-URINE Pacific Biotech, Inc. | JHI |
| Oct 25, 1989 | K894941 | COAT-A-COUNT (TM) HCG IRMA Diagnostic Products Corp. | JHI |
| Oct 25, 1989 | K894790 | QUIDEL HCG TEST Quidel Corp. | JHI |
| Oct 18, 1989 | K894750 | BIOSTIX I. HCG - ONE STEP PREGNANCY TEST Princeton Biomedix | JHI |
| Oct 18, 1989 | K894705 | BIOSPOT HCG-RAPID PREGNANCY TEST Princeton Biomedix | JHI |
| Oct 4, 1989 | K894420 | ORTHO RESULT PLUS/PREGNANCY Ortho Diagnostic Systems, Inc. | JHI |
| Sep 26, 1989 | K894182 | IMX TOTAL B-HCG Abbott Laboratories | JHI |
| Sep 5, 1989 | K894408 | ABBOTT TESTPACK PLUS HCG URINE Abbott Laboratories | JHI |
| Jul 25, 1989 | K894012 | MINICLINIC PREGNANCY TEST Vanguard Biomedical Corp. | JHI |
| May 24, 1989 | K891770 | HCG IRMA II Pacific Biotech, Inc. | JHI |
| Apr 18, 1989 | K890615 | DIRECTIGEN1-2-3 BHCG PREGNANCY TEST Quidel Corp. | JHI |
| Mar 28, 1989 | K890549 | VENTREX COATED TUBE HCG Ventrex Laboratories, Inc. | JHI |
| Mar 9, 1989 | K890131 | TARGET(TM) QUANTITATIVE HCG V-Tech, Inc. | JHI |
| Jan 13, 1989 | K884880 | PREGNAGEN(TM) Biogenex Laboratories | JHI |
| Jan 13, 1989 | K884616 | FIRSTDAY EARLY PREGNANCY TESTING KIT II Pacific Biotech, Inc. | JHI |
| Oct 13, 1988 | K883927 | CIBA CORNING MAGIC LITE HCG IMMUNOASSAY Ciba Corning Diagnostics Corp. | JHI |
| Oct 6, 1988 | K883777 | CLEARVIEW HCG Unipath , Ltd., GB | JHI |
| Oct 6, 1988 | K883639 | MODIFIED HCG IRMA KIT Pacific Biotech, Inc. | JHI |
| Sep 9, 1988 | K882002 | PREGNAGEN(TM) Biogenex Laboratories | JHI |
| Aug 29, 1988 | K881015 | FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT Pacific Biotech, Inc. | JHI |
| Aug 8, 1988 | K882155 | COTUBE HCG IRMA TEST Bio-Rad | JHI |
| Aug 2, 1988 | K881806 | QLT ABSOLUTE URINE-HCG PREGNANCY TEST Quadra Logic Technologies, Inc., CA | JHI |
| Jul 28, 1988 | K882086 | QTEST(TM) PREGNANCY Quidel Corp. | JHI |
| Jul 8, 1988 | K881709 | IMMUNOCARD(TM) HCG II TEST KIT Disease Detection International, Inc. | JHI |
| Jun 8, 1988 | K881355 | AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT Amersham Corp. | JHI |
| May 27, 1988 | K881595 | QUIDEL PREGNANCY TEST Quidel Corp. | JHI |
| May 27, 1988 | K881005 | IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG Icn Biomedicals, Inc. | JHI |
| Apr 5, 1988 | K880410 | HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT Disease Detection International, Inc. | JHI |
| Mar 24, 1988 | K880070 | ABBOTT IMX HCG Abbott Laboratories | JHI |
| Mar 15, 1988 | K880577 | CONCEP-7-BHCG Leeco Diagnostics, Inc. | JHI |
| Feb 8, 1988 | K874388 | KODAK SURECELL(TM) HCG-URINE KIT Eastman Kodak Company | JHI |
| Jan 5, 1988 | K874033 | IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X Diagnostic Products Corp. | JHI |
| Nov 23, 1987 | K874258 | VENTRESCREEN, HCG URINE Ventrex Laboratories, Inc. | JHI |
| Nov 23, 1987 | K873788 | CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504 Pacific Biotech, Inc. | JHI |
| Oct 20, 1987 | K872730 | RESULT PLUS/HCG PREGNANCY TEST Ortho Diagnostic Systems, Inc. | JHI |
| Oct 6, 1987 | K873524 | AFFINITY HCG IMMUNIT (POLYCLONAL) Bd Becton Dickinson Vacutainer Systems Preanalytic | JHI |
| Sep 14, 1987 | K873033 | HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE Serono Diagnostics, Inc. | JHI |
| Sep 2, 1987 | K872390 | ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM Nichols Institute Diagnostics | JHI |
| Aug 5, 1987 | K872728 | BINAX IRMA TOTAL BETA-HCG TEST KIT Binax, Inc. | JHI |
| Jul 16, 1987 | K872130 | ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES Syva Co. | JHI |
| Jul 15, 1987 | K871700 | HCG MAB SOLID PHASE COMPONENT SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | JHI |
| Jun 11, 1987 | K871308 | ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT Allelix, Inc., CA | JHI |
| Jun 3, 1987 | K871235 | TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT Hybritech, Inc. | JHI |
| May 28, 1987 | K870627 | AFFINITY (TM) HCG IMMUNIT (TM) Bd Becton Dickinson Vacutainer Systems Preanalytic | JHI |
| May 20, 1987 | K870751 | SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST Syntron Bioresearch, Inc. | JHI |
| May 20, 1987 | K870739 | ABBOTT TESTPACK HCG COMBO Abbott Laboratories | JHI |
| Apr 8, 1987 | K870521 | TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY Hybritech, Inc. | JHI |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.