JHI · Class II · 21 CFR 862.1155

FDA Product Code JHI: Visual, Pregnancy Hcg, Prescription Use

Leading manufacturers include Quidel Corp., Abbott Laboratories and Hybritech, Inc..

375
Total
375
Cleared
70d
Avg days
1976
Since
375 devices
97–120 of 375
Cleared Apr 18, 1989
DIRECTIGEN1-2-3 BHCG PREGNANCY TEST
K890615
Quidel Corp.
Chemistry · 70d
Cleared Mar 28, 1989
VENTREX COATED TUBE HCG
K890549
Ventrex Laboratories, Inc.
Chemistry · 53d
Cleared Oct 13, 1988
CIBA CORNING MAGIC LITE HCG IMMUNOASSAY
K883927
Ciba Corning Diagnostics Corp.
Chemistry · 28d
Cleared Oct 06, 1988
CLEARVIEW HCG
K883777
Unipath , Ltd.
Chemistry · 30d
Cleared Aug 08, 1988
COTUBE HCG IRMA TEST
K882155
Bio-Rad
Chemistry · 80d
Cleared Jul 28, 1988
QTEST(TM) PREGNANCY
K882086
Quidel Corp.
Chemistry · 71d
Cleared Jun 08, 1988
AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT
K881355
Amersham Corp.
Chemistry · 51d
Cleared May 27, 1988
QUIDEL PREGNANCY TEST
K881595
Quidel Corp.
Chemistry · 45d
Cleared Mar 24, 1988
ABBOTT IMX HCG
K880070
Abbott Laboratories
Chemistry · 72d
Cleared Mar 15, 1988
CONCEP-7-BHCG
K880577
Leeco Diagnostics, Inc.
Chemistry · 34d
Cleared Feb 08, 1988
KODAK SURECELL(TM) HCG-URINE KIT
K874388
Eastman Kodak Company
Chemistry · 104d
Cleared Jan 05, 1988
IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X
K874033
Diagnostic Products Corp.
Immunology · 95d
Cleared Nov 23, 1987
VENTRESCREEN, HCG URINE
K874258
Ventrex Laboratories, Inc.
Chemistry · 34d
Cleared Oct 20, 1987
RESULT PLUS/HCG PREGNANCY TEST
K872730
Ortho Diagnostic Systems, Inc.
Chemistry · 104d
Cleared Oct 06, 1987
AFFINITY HCG IMMUNIT (POLYCLONAL)
K873524
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 35d
Cleared Sep 02, 1987
ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM
K872390
Nichols Institute Diagnostics
Chemistry · 75d
Cleared Jul 16, 1987
ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES
K872130
Syva Co.
Chemistry · 44d
Cleared Jul 15, 1987
HCG MAB SOLID PHASE COMPONENT SYSTEM
K871700
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 75d
Cleared Jun 03, 1987
TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT
K871235
Hybritech, Inc.
Chemistry · 68d
Cleared May 28, 1987
AFFINITY (TM) HCG IMMUNIT (TM)
K870627
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 104d
Cleared May 20, 1987
ABBOTT TESTPACK HCG COMBO
K870739
Abbott Laboratories
Chemistry · 83d
Cleared Apr 08, 1987
TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY
K870521
Hybritech, Inc.
Chemistry · 61d
Cleared Apr 01, 1987
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD
K870672
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 41d
Cleared Mar 13, 1987
COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS
K870106
Diagnostic Products Corp.
Chemistry · 60d