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
121–144 of 375
Cleared Feb 02, 1993
SAS ONE STEP PREGNANCY
K926204
Sa Scientific, Inc.
Chemistry · 55d
Cleared Jan 13, 1993
PRO-STEP HCG
K925125
Disease Detection International, Inc.
Chemistry · 92d
Cleared Dec 03, 1992
QUICKVUE ONE-STEP HCG TEST
K925435
Quidel Corp.
Chemistry · 36d
Cleared Nov 25, 1992
MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100
K924259
Medix Biotech, Inc.
Chemistry · 93d
Cleared Oct 01, 1992
VISUAL HCG PREGNANCY TEST
K923376
Tech-Co, Inc.
Chemistry · 84d
Cleared Aug 10, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD
K922697
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 67d
Cleared Jul 28, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921302
Vitek Systems, Inc.
Chemistry · 131d
Cleared Jul 09, 1992
SINGLE-STEP PREGNANCY, HCG TEST
K922290
American Medical Products, Inc.
Chemistry · 55d
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 Oct 11, 1991
TARGET(TM)-HOG
K914303
V-Tech, Inc.
Chemistry · 16d
Cleared Aug 16, 1991
DIRECTIGEN 1-2-3(TM) HCG TEST
K913122
Quidel Corp.
Chemistry · 32d
Cleared Jul 19, 1991
IMMUNOCARD HCG ONE STEP (I-S) TEST KIT
K911826
Disease Detection International, Inc.
Chemistry · 86d
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 22, 1990
TARGET(TM) HOG ONE STEP
K903937
V-Tech, Inc.
Chemistry · 56d
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