Medical Device Manufacturer · US , Mission Viejo , CA

Sd Biosensor, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2015

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sd Biosensor, Inc. Chemistry ✕

2 devices

1-2 of 2

Cleared Sep 30, 2015

SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set

Chemistry · 547d

Cleared Aug 05, 2015

SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD...

Chemistry · 687d