Medical Device Manufacturer · US , Pipersville , PA

Specialized Assays, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1997

Recent clearances: STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003), STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001), STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002)

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Specialized Assays, Inc. Chemistry ✕

3 devices

1-3 of 3

Cleared Feb 06, 1997

STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)

Chemistry · 44d

Cleared Feb 04, 1997

STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)

Chemistry · 42d

Cleared Feb 04, 1997

STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002)

Chemistry · 42d