JHI · Class II · 21 CFR 862.1155

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

Leading manufacturers include Abbott Laboratories, Bd Becton Dickinson Vacutainer Systems Preanalytic and Eastman Kodak Company.

375
Total
375
Cleared
70d
Avg days
1976
Since
375 devices
25–48 of 375
Cleared Sep 26, 1989
IMX TOTAL B-HCG
K894182
Abbott Laboratories
Chemistry · 102d
Cleared Sep 05, 1989
ABBOTT TESTPACK PLUS HCG URINE
K894408
Abbott Laboratories
Chemistry · 50d
Cleared Aug 08, 1988
COTUBE HCG IRMA TEST
K882155
Bio-Rad
Chemistry · 80d
Cleared Mar 24, 1988
ABBOTT IMX HCG
K880070
Abbott Laboratories
Chemistry · 72d
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 Oct 06, 1987
AFFINITY HCG IMMUNIT (POLYCLONAL)
K873524
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 35d
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 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 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
Cleared Feb 04, 1987
HCG SOLID PHASE COMPONENT SYSTEM
K864591
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 75d
Cleared Sep 15, 1986
ABBOTT TESTPACK (TM) HCG SERUM
K863032
Abbott Laboratories
Chemistry · 35d
Cleared Sep 25, 1985
ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT
K853539
Abbott Laboratories
Chemistry · 33d
Cleared Jul 09, 1985
BETA HCG EXTENDED RANGE ACCESSORY KIT
K852183
Abbott Laboratories
Chemistry · 50d
Cleared Jun 28, 1985
ECHOCLONAL HCG IRMA
K852201
Bio-Rad
Chemistry · 38d
Cleared Oct 01, 1984
EPSILON HCG TEST KIT MONOCLONAL
K842654
Beckman Instruments, Inc.
Immunology · 83d
Cleared Jun 02, 1983
ARIA II I-HCG
K830997
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 65d
Cleared Mar 29, 1983
BETA-COTE B-HCG PREGNANCY SCREENING SYS
K830695
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 22d
Cleared Sep 02, 1982
B-HCG
K822343
Diagnostic Products Corp.
Chemistry · 28d
Cleared Mar 11, 1982
ABBOTT LABORATORIES B-HCG EIA
K820271
Abbott Laboratories
Chemistry · 37d
Cleared Jul 10, 1981
HCG RADIOIMMUNOASSAY KIT (125I)
K811421
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 51d