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
241–264 of 375
Cleared Mar 19, 1984
HCG RIA
K833851
Syncor Intl. Corp.
Chemistry · 136d
Cleared Feb 03, 1984
TANDEM VISUAL HCG IMMUNOENZYMETRIC
K834000
Hybritech, Inc.
Chemistry · 74d
Cleared Jan 24, 1984
STAR HCG MONOCLONAL ANTIBODY IMMUNORAD
K832796
Syncor Intl. Corp.
Chemistry · 159d
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 Oct 28, 1983
MODIFIED CHORIO-SHURE
K832892
Nuclear Medical Laboratories, Inc.
Chemistry · 63d
Cleared Jun 08, 1983
BHCG RIA KIT
K831264
Micromedic Systems
Chemistry · 51d
Cleared Jun 08, 1983
PBI BHCG RIA KIT
K831302
Pacific Biotech, Inc.
Chemistry · 48d
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 Jun 02, 1983
BETA-QUIK-15 RIA KIT
K831223
Pacific Biotech, Inc.
Chemistry · 48d
Cleared Apr 05, 1983
B-GCG SYSTEM BY RIA
K830526
Pcl-Ria, Inc.
Chemistry · 47d
Cleared Mar 29, 1983
BETA-COTE B-HCG PREGNANCY SCREENING SYS
K830695
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 22d
Cleared Feb 18, 1983
DAC-CEL DIAGNATAL RD 50
K830203
Wellcome Diagnostics
Chemistry · 29d
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 Dec 22, 1982
IN VITRO GAMMACOAT B-HCG RADIO. TEST
K823313
Clinical Assays, Inc.
Chemistry · 47d
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
Cleared Apr 01, 1982
ROCHE B-HCG STANDARDS
K820614
Hoffmann-La Roche, Inc.
Chemistry · 24d