Medical Device Manufacturer · US , Salt Lake City , UT

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

28 submissions · 24 cleared · Since 2015
Official Website
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
K143080 · OCC
Microbiology · 113d
Cleared Jan 30, 2015
FilmArray Blood Culture Identification (BCID) Panel for use with the...
K143171 · PEN
Microbiology · 87d
Cleared Jan 30, 2015
FilmArray 2.0 System
K143178 · NSU
Microbiology · 87d
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