Medical Device Manufacturer · US , San Leandro , CA

Unotech Diagnostics, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1997

Recent clearances: ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005, ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002, ACCUTEST HCG-URINE

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Unotech Diagnostics, Inc. Chemistry ✕

3 devices

1-3 of 3

Cleared Nov 17, 2003

ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005

Chemistry · 54d

Cleared Jun 25, 1998

ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002

Chemistry · 30d

Cleared Jun 11, 1997

ACCUTEST HCG-URINE

Chemistry · 20d