FilmArray 2.0 System— 510(k) K143178

Substantially Equivalent

Biofire Diagnostics, LLC

FDA 510(k) clearance K143178 for FilmArray 2.0 System, Substantially Equivalent on 2015-01-30. Applicant: Biofire Diagnostics, LLC.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code NSU
Advisory panel: Clinical Chemistry
Date received: 2014-11-04
Decision date: 2015-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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