Medical Device Manufacturer · US , San Diego , CA

Mesa Biotech, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2018

Recent clearances: Accula Strep A Test, Accula RSV Test, Accula Flu A/Flu B Test

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mesa Biotech, Inc. Microbiology ✕

3 devices

1-3 of 3

Cleared Nov 09, 2020

Accula Strep A Test

Microbiology · 181d

Cleared Nov 23, 2018

Accula RSV Test

Microbiology · 176d

Cleared Feb 06, 2018

Accula Flu A/Flu B Test

Microbiology · 249d