Medical Device Manufacturer · US , Salt Lake City , UT

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

29 submissions · 25 cleared · Since 2015

View 29 510(k) Devices ↓ Official Website

29

Total

25

Cleared

4

Denied

29 devices

26-29 of 29

Cleared Feb 19, 2015

FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0

Microbiology · 122d

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