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
145–168 of 375
Cleared Nov 21, 1984
QUEST BETA HCG ENZYME IMMUNOASSAY KIT
K844082
Quidel Corp.
Immunology · 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 Jun 22, 1984
CA-1511, IN VITRO RADIOIMMUNOASSAY
K841821
Travenol Laboratories, S.A.
Chemistry · 51d
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 Feb 03, 1984
TANDEM VISUAL HCG IMMUNOENZYMETRIC
K834000
Hybritech, Inc.
Chemistry · 74d
Cleared Jan 18, 1984
TANDEM R-TOTAL B-GCG KIT
K833194
Hybritech, Inc.
Chemistry · 121d
Cleared Dec 08, 1983
OREIA II B-HCG, ENZYME INNUNOASSAY
K832801
Organon, Inc.
Chemistry · 112d
Cleared Jun 08, 1983
BHCG RIA KIT
K831264
Micromedic Systems
Chemistry · 51d
Cleared Jun 02, 1983
ARIA II I-HCG
K830997
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 65d
Cleared Jun 02, 1983
DUOCLON SLIDE TEST
K831109
Organon, Inc.
Immunology · 58d
Cleared Mar 29, 1983
BETA-COTE B-HCG PREGNANCY SCREENING SYS
K830695
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 22d
Cleared Feb 07, 1983
TANDEM E GCG VISUAL END POINT INNUMOENZ
K830138
Hybritech, Inc.
Chemistry · 25d
Cleared Jan 24, 1983
GENESIS B-HCG
K823753
Armkel, LLC
Chemistry · 41d
Cleared Sep 02, 1982
B-HCG
K822343
Diagnostic Products Corp.
Chemistry · 28d
Cleared Jul 22, 1982
TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT
K821944
Hybritech, Inc.
Chemistry · 23d
Cleared May 03, 1982
ROCHE(R) B-HCG RIA URINE STANDARD
K820942
Hoffmann-La Roche, Inc.
Chemistry · 27d
Cleared May 03, 1982
AMERLEX B-LCG RIA KIT
K821031
Amersham Corp.
Chemistry · 20d
Cleared Apr 29, 1982
TANDEM HCG KIT
K820822
Hybritech, Inc.
Chemistry · 36d
Cleared Apr 01, 1982
ROCHE B-HCG RIA
K820613
Hoffmann-La Roche, Inc.
Chemistry · 24d