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
73–96 of 375
Cleared Mar 23, 1992
AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR
K920505
Eastman Kodak Company
Chemistry · 47d
Cleared Feb 14, 1992
MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT
K920253
Medix Biotech, Inc.
Chemistry · 24d
Cleared Jan 27, 1992
KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION
K915701
Eastman Kodak Company
Chemistry · 49d
Cleared Nov 13, 1991
MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011
K914696
Medix Biotech, Inc.
Chemistry · 26d
Cleared Oct 25, 1991
CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF
K914240
Unipath , Ltd.
Chemistry · 51d
Cleared Aug 16, 1991
DIRECTIGEN 1-2-3(TM) HCG TEST
K913122
Quidel Corp.
Chemistry · 32d
Cleared Jul 01, 1991
IMX HCG
K912534
Abbott Laboratories
Chemistry · 24d
Cleared Jul 01, 1991
IMX TOTAL B-HCG
K912535
Abbott Laboratories
Chemistry · 24d
Cleared May 15, 1991
CLEARVIEW HCG SERUM/URINE
K905741
Unipath , Ltd.
Chemistry · 142d
Cleared Oct 03, 1990
CIBA CORNING ACS HCG IMMUNOASSAY
K904123
Ciba Corning Diagnostics Corp.
Chemistry · 27d
Cleared Sep 25, 1990
ABBOTT TESTPACK PLUS TM HCG-COMBO
K903219
Abbott Laboratories
Chemistry · 64d
Cleared Aug 09, 1990
AFFINITY HCG TEST SYSTEM
K902720
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 50d
Cleared Jun 28, 1990
KODAK SURECELL(TM) HCG-URINE TEST KIT
K902136
Eastman Kodak Company
Chemistry · 49d
Cleared Jun 26, 1990
OPUS (TM) HCG
K901935
Pb Diagnostic Systems, Inc.
Toxicology · 57d
Cleared Apr 18, 1990
IMX HCG (LIST #03A63)
K900327
Abbott Laboratories
Chemistry · 85d
Cleared Mar 29, 1990
HCG SOLID PHASE COMPONENT SYSTEM
K901045
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology · 23d
Cleared Feb 16, 1990
MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT
K896587
Medix Biotech, Inc.
Chemistry · 87d
Cleared Feb 08, 1990
ENZYMUN TEST R HCG
K896901
Boehringer Mannheim Corp.
Chemistry · 62d
Cleared Dec 01, 1989
MILENIA(TM) HCG (MKCG1,5)
K895809
Diagnostic Products Corp.
Chemistry · 90d
Cleared Oct 25, 1989
QUIDEL HCG TEST
K894790
Quidel Corp.
Chemistry · 89d
Cleared Oct 25, 1989
COAT-A-COUNT (TM) HCG IRMA
K894941
Diagnostic Products Corp.
Chemistry · 83d
Cleared Oct 04, 1989
ORTHO RESULT PLUS/PREGNANCY
K894420
Ortho Diagnostic Systems, Inc.
Chemistry · 79d
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