Medical Device Manufacturer · US , Salt Lake City , UT

Biofire Diagnostics, LLC - FDA 510(k) Cleared Devices

28 submissions · 24 cleared · Since 2015

28

Total

24

Cleared

4

Denied

28 devices

26-28 of 28

Cleared Feb 17, 2015

FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System

Microbiology · 113d

Cleared Jan 30, 2015

FilmArray Blood Culture Identification (BCID) Panel for use with the...

Microbiology · 87d

Cleared Jan 30, 2015

FilmArray 2.0 System

Microbiology · 87d