Medical Device Manufacturer · US , Bethlehem , PA

OraSure Technologies, Inc. - FDA 510(k) Cleared Devices

30 submissions · 29 cleared · Since 1996

30

Total

29

Cleared

1

Denied

30 devices

26-30 of 30

Cleared Jan 28, 1998

STC METHAMPHETAMINE MICRO-PLATE EIA

Toxicology · 169d

Cleared Jan 02, 1998

STC COCAINE METABOLITE MICRO-PLATE EIA

Toxicology · 99d

Cleared Oct 21, 1997

HISTOFREEZER VERRUCA PLANA

General & Plastic Surgery · 189d

Cleared Oct 21, 1997

AUTO-LYTE COTININE EIA

Toxicology · 111d

Cleared Dec 26, 1996

STC AUTO-LYTE URINARY GLUCOSE ASSAY

Chemistry · 185d