FilmArray Global Fever Panel External Control Kit— 510(k) K202382

Name: FDA 510(k) clearance K202382
Creator: U.S. Food and Drug Administration
Published: 2020-11-20

Substantially Equivalent

Biofire Defense, LLC

FDA 510(k) clearance K202382 for FilmArray Global Fever Panel External Control Kit, Substantially Equivalent on 2020-11-20. Applicant: Biofire Defense, LLC. Device class: 2.

Clearance details

Applicant: Biofire Defense, LLC
Product code: Code PMN
Device class: Class 2
Regulation: 21 CFR 866.3920
Advisory panel: Microbiology
Date received: 2020-08-20
Decision date: 2020-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.