FilmArray Global Fever Panel— 510(k) DEN200043

Unknown

Biofire Defense, LLC

FDA 510(k) clearance DEN200043 for FilmArray Global Fever Panel, Unknown on 2020-11-20. Applicant: Biofire Defense, LLC. Device class: 2.

Clearance details

Applicant: Biofire Defense, LLC
Product code: Code QMV
Device class: Class 2
Regulation: 21 CFR 866.3966
Advisory panel: Microbiology
Date received: 2020-06-26
Decision date: 2020-11-20
Decision: Unknown
Clearance type: Direct
Location: Salt Lake City, UT, US

View on FDA.gov ↗

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