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
217–240 of 375
Cleared Jun 25, 1985
BHCG-ROCHE EIA
K850727
Hoffmann-La Roche, Inc.
Chemistry · 123d
Cleared May 10, 1985
UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST
K851076
United Biotech, Inc.
Chemistry · 53d
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
Cleared Nov 21, 1984
QUEST BETA HCG ENZYME IMMUNOASSAY KIT
K844082
Quidel Corp.
Immunology · 33d
Cleared Oct 30, 1984
BETA QUIK V
K843795
Pacific Biotech, Inc.
Chemistry · 33d
Cleared Oct 04, 1984
ENCORE HCG REAGENT
K843407
Hybritech, Inc.
Chemistry · 34d
Cleared Oct 01, 1984
EPSILON HCG TEST KIT MONOCLONAL
K842654
Beckman Instruments, Inc.
Immunology · 83d
Cleared Sep 05, 1984
QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT
K842692
Quidel Corp.
Chemistry · 56d
Cleared Aug 23, 1984
TANDEM FAST VISUAL HCG ASSAY KIT -
K842633
Hybritech, Inc.
Chemistry · 45d
Cleared Jul 26, 1984
STAR HCG MONOCLONAL ANTIBODY IMMUNO
K842598
Syncor Intl. Corp.
Chemistry · 35d
Cleared Jun 22, 1984
CA-1511, IN VITRO RADIOIMMUNOASSAY
K841821
Travenol Laboratories, S.A.
Chemistry · 51d
Cleared Jun 22, 1984
BHCG RIA
K841854
Syncor Intl. Corp.
Chemistry · 50d
Cleared Jun 05, 1984
OREIA II B-HCG PREGNANCY TEST KIT
K841525
Organon, Inc.
Chemistry · 54d
Cleared May 07, 1984
VENTREZYME BETA-HCG IMMUNOASSAY HCG
K841081
Ventrex Laboratories, Inc.
Chemistry · 55d
Cleared May 01, 1984
COATED TUBE HCG IMMUNOASSAY HCG
K841023
Ventrex Laboratories, Inc.
Chemistry · 50d
Cleared Mar 19, 1984
HCG RIA
K833851
Syncor Intl. Corp.
Chemistry · 136d