FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch— 510(k) K160459

Clearance details

Applicant

Biofire Diagnostics, LLC

Product code

Code PCH

Device class

Class 2

Regulation

21 CFR 866.3990

Advisory panel

Microbiology

Date received

2016-02-19

Decision date

2016-04-01

Decision

Substantially Equivalent

Clearance type

Special

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 K160459.