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
265–288 of 375
Cleared Mar 15, 1982
CHORIO-QUANT
K820523
Nuclear Medical Laboratories, Inc.
Chemistry · 17d
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 29, 1981
EARLY PREGNANCY DETECTION
K811398
Immuchem Corp.
Chemistry · 11d
Cleared May 13, 1981
HCG RADIOIMMUNOASSAY
K811116
Hoffmann-La Roche, Inc.
Chemistry · 19d
Cleared Apr 17, 1981
DAC-CEL HCG
K810215
Burroughs Wellcome Co.
Chemistry · 80d
Cleared Apr 17, 1981
CHORIO-SHURE
K810936
Nuclear Medical Laboratories, Inc.
Chemistry · 10d
Cleared Mar 06, 1981
DAC-CEL DIAGNATAL
K810214
Burroughs Wellcome Co.
Chemistry · 38d
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
HUMAN CHORIONIC GONADOTROPIN (RIA)
K792197
Nuclear Medical Laboratories, Inc.
Chemistry · 35d
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 Jul 17, 1979
HUMAN CHORIONIC GONADOTROPHIN STANDARDS
K790863
Pcl-Ria, Inc.
Chemistry · 71d
Cleared Jul 17, 1979
RABBIT ANTISERUM TO HUMAN CHORIONIC
K790864
Pcl-Ria, Inc.
Chemistry · 71d
Cleared Jul 17, 1979
LABELED HUMAN CHORIONIC GONADOTROPHIN
K790876
Pcl-Ria, Inc.
Chemistry · 71d
Cleared May 23, 1979
CONCEP-7-B-HCG
K790397
Leeco Diagnostics, Inc.
Chemistry · 86d
Cleared Mar 12, 1979
CHORIC-SHURE
K790138
Nuclear Medical Laboratories, Inc.
Chemistry · 49d
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