FilmArray Pneumonia Panel

Respiratory Panel

BioFire Diagnostics, LLC

The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray Pneumonia Panel.

Pre-market Notification Details

Device IDK212727
510k NumberK212727
Device Name:FilmArray Pneumonia Panel
ClassificationRespiratory Panel
Applicant BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City,  UT  84108
ContactKevin Bourzac
CorrespondentKevin Bourzac
BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City,  UT  84108
Product CodeQDP  
CFR Regulation Number866.3985 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-27
Decision Date2021-09-22

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