Medical Device Manufacturer · US , Seattle , WA

Ostex Intl., Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1995

Recent clearances: OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE, OSTEOMARK NTX SERUM EIA, OSTEOMARK

View 5 510(k) Devices ↓

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ostex Intl., Inc. Chemistry ✕

5 devices

1-5 of 5

Cleared Jul 30, 2001

OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE

Chemistry · 115d

Cleared Feb 02, 1999

OSTEOMARK NTX SERUM EIA

Chemistry · 125d

Cleared Mar 06, 1998

Chemistry · 49d

Cleared Jul 11, 1996

Chemistry · 80d

Cleared May 08, 1995

Chemistry · 154d