Medical Device Manufacturer · US , Bethlehem , PA

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

30 submissions · 29 cleared · Since 1996

Recent clearances: COMPOUND W FREEZE OFF WART REMOVAL SYSTEM, HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME, OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I

30

Total

29

Cleared

1

Denied

FDA 510(k) Regulatory Record - OraSure Technologies, Inc. General & Plastic Surgery ✕

6 devices

1-6 of 6

Cleared Jul 18, 2006

COMPOUND W FREEZE OFF WART REMOVAL SYSTEM

General & Plastic Surgery · 112d

Cleared Mar 20, 2003

HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME

General & Plastic Surgery · 154d

Cleared Jun 14, 1999

HISTOFREEZER DEVICE

General & Plastic Surgery · 90d

Cleared Oct 02, 1998

HISTOFREEZER DEVICE

General & Plastic Surgery · 88d

Cleared May 26, 1998

HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS

General & Plastic Surgery · 90d

Cleared Oct 21, 1997

HISTOFREEZER VERRUCA PLANA

General & Plastic Surgery · 189d