Medical Device Manufacturer · US , Northridge , CA

Quantech , Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1999

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Quantech , Ltd. Chemistry ✕

3 devices

1-3 of 3

Cleared Jan 18, 2002

THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG...

Chemistry · 140d

Cleared Dec 21, 1999

QUANTECH TOTAL B-HCG ASSAY

Chemistry · 328d

Cleared Nov 01, 1999

QUANTECH CK-MB ASSAY

Chemistry · 322d