K143005

Substantially Equivalent

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

Applicant: Biofire Diagnostics, LLC
Product code: PCH
Advisory panel: Microbiology
Date received: 2014-10-20
Decision date: 2015-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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