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

FDA 510(k) Regulatory Record - OraSure Technologies, Inc. Microbiology ✕

1 devices

1-1 of 1

Not Cleared Oct 10, 2019

OraQuick Ebola Rapid Antigen Test

DEN190025 · QID

Microbiology · 150d