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
193–216 of 375
Cleared Apr 01, 1987
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD
K870672
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 41d
Cleared Mar 13, 1987
UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE
K864174
United Biotech, Inc.
Chemistry · 140d
Cleared Mar 13, 1987
COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS
K870106
Diagnostic Products Corp.
Chemistry · 60d
Cleared Mar 10, 1987
TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY
K865057
Hybritech, Inc.
Chemistry · 76d
Cleared Mar 10, 1987
VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044
K870259
Leeco Diagnostics, Inc.
Chemistry · 46d
Cleared Feb 11, 1987
SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST
K865076
Syntron Bioresearch, Inc.
Chemistry · 44d
Cleared Feb 04, 1987
HCG SOLID PHASE COMPONENT SYSTEM
K864591
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 75d
Cleared Dec 15, 1986
VIS-CUBE HCG (EIA)
K863933
Leeco Diagnostics, Inc.
Chemistry · 68d
Cleared Nov 21, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA
K863861
Hybritech, Inc.
Chemistry · 49d
Cleared Sep 15, 1986
ABBOTT TESTPACK (TM) HCG SERUM
K863032
Abbott Laboratories
Chemistry · 35d
Cleared Sep 15, 1986
CARDS(TM) HCG-URINE
K863199
Pacific Biotech, Inc.
Chemistry · 27d
Cleared Jul 29, 1986
TARGET HCG, ENZYME IMMUNOASSAY REAGENTS
K862247
V-Tech, Inc.
Chemistry · 47d
Cleared Jul 29, 1986
HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS
K862262
Serono Diagnostics, Inc.
Chemistry · 46d
Cleared Jul 01, 1986
HCG IRMA, CAT. NO. CR-1501
K862007
Pacific Biotech, Inc.
Chemistry · 35d
Cleared Apr 24, 1986
BETA QUIK STICK
K860965
Pacific Biotech, Inc.
Chemistry · 42d
Cleared Mar 05, 1986
MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY
K860490
Medix Biotech, Inc.
Chemistry · 23d
Cleared Mar 05, 1986
TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT
K860542
Hybritech, Inc.
Chemistry · 21d
Cleared Jan 28, 1986
HCG RIA TEST SYSTEM
K854958
Monobind
Chemistry · 48d
Cleared Dec 05, 1985
LBK 1244 DELFIA HCG KIT
K852760
Lkb Instruments, Inc.
Chemistry · 160d
Cleared Nov 26, 1985
CORNING MAGIC MAB HCG RADIOIMMUNOASSAY
K854024
Corning Medical & Scientific
Chemistry · 57d
Cleared Sep 25, 1985
ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT
K853539
Abbott Laboratories
Chemistry · 33d
Cleared Aug 20, 1985
BETA QUIK STAT
K852327
Pacific Biotech, Inc.
Chemistry · 82d
Cleared Jul 22, 1985
AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT
K852675
Amersham Corp.
Chemistry · 28d
Cleared Jul 09, 1985
BETA HCG EXTENDED RANGE ACCESSORY KIT
K852183
Abbott Laboratories
Chemistry · 50d