FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0— 510(k) K143005

Substantially Equivalent

Biofire Diagnostics, LLC

FDA 510(k) clearance K143005 for FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0, Substantially Equivalent on 2015-02-19. Applicant: Biofire Diagnostics, LLC.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: 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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