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
169–192 of 375
Cleared Apr 01, 1982
ROCHE B-HCG STANDARDS
K820614
Hoffmann-La Roche, Inc.
Chemistry · 24d
Cleared Mar 11, 1982
ABBOTT LABORATORIES B-HCG EIA
K820271
Abbott Laboratories
Chemistry · 37d
Cleared Mar 11, 1982
IMMOPHASE B HCG RADIOIMMUNOASSAY
K820321
Corning Medical & Scientific
Chemistry · 34d
Cleared Oct 13, 1981
TANDEM QUALITATIVE HCG KIT
K812461
Hybritech, Inc.
Chemistry · 43d
Cleared Aug 20, 1981
CONCEP-7-BHCG
K812156
Leeco Diagnostics, Inc.
Chemistry · 22d
Cleared Jul 10, 1981
HCG RADIOIMMUNOASSAY KIT (125I)
K811421
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 51d
Cleared May 13, 1981
HCG RADIOIMMUNOASSAY
K811116
Hoffmann-La Roche, Inc.
Chemistry · 19d
Cleared Dec 22, 1980
BETA-TEC QUALITATIVE
K802999
Armkel, LLC
Chemistry · 27d
Cleared Jul 14, 1980
GAMMADAB B-HCG RADIOIMMUNOASSAY KIT
K801409
Travenol Laboratories, S.A.
Chemistry · 28d
Cleared Jun 20, 1980
ROCHE HCG STANDARDS
K801244
Hoffmann-La Roche, Inc.
Chemistry · 24d
Cleared Dec 06, 1979
CONCEP-7-BHCG
K792308
Leeco Diagnostics, Inc.
Chemistry · 20d
Cleared Jul 30, 1979
HCG RIA PREGNANCY TEST
K791206
Hoffmann-La Roche, Inc.
Chemistry · 31d
Cleared May 23, 1979
CONCEP-7-B-HCG
K790397
Leeco Diagnostics, Inc.
Chemistry · 86d
Cleared Oct 10, 1978
RIA QUANT B-HCG TEST KIT
K781578
Mallinckrodt Critical Care
Chemistry · 25d
Cleared Nov 23, 1977
QUANTROLS HCG
K772086
Organon, Inc.
Chemistry · 20d