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510k Database
Manufacturers
US
Biofire Diagnostics, LLC
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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
Filters
1
2
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
1
2
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28
Microbiology
28