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

Clearance details

Applicant

Biofire Diagnostics, LLC

Product code

Code PCH

Device class

Class 2

Regulation

21 CFR 866.3990

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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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143005.