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 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 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 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 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 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
Cleared Jun 28, 1985
ECHOCLONAL HCG IRMA
K852201
Bio-Rad
Chemistry · 38d
Cleared Jun 25, 1985
BHCG-ROCHE EIA
K850727
Hoffmann-La Roche, Inc.
Chemistry · 123d
Cleared May 01, 1985
PREGNA-ZYME
K850992
Armkel, LLC
Chemistry · 51d
Cleared Apr 12, 1985
MEDIX VISUAL URINE HCG (7/7) TEST
K850949
Medix Biotech, Inc.
Chemistry · 36d
Cleared Apr 08, 1985
MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM
K850987
Medix Biotech, Inc.
Chemistry · 28d
Cleared Apr 02, 1985
LEECO CONCEP-7-BHCG IRMA
K850530
Leeco Diagnostics, Inc.
Chemistry · 50d
Cleared Apr 02, 1985
LEECO CONCEP-7-BHCG EIA
K850531
Leeco Diagnostics, Inc.
Chemistry · 50d
Cleared Apr 02, 1985
STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K850570
American Dade
Chemistry · 48d
Cleared Mar 04, 1985
TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT
K850159
Hybritech, Inc.
Chemistry · 48d
Cleared Mar 04, 1985
LEECO CONCEP-7-BHCG LEIAD II
K850201
Leeco Diagnostics, Inc.
Chemistry · 45d
Cleared Dec 14, 1984
CONCEP-7-BHCG (EIA)
K844153
Leeco Diagnostics, Inc.
Chemistry · 51d