BioFire COVID-19 Test 2— 510(k) K211079

Substantially Equivalent

Biofire Defense, LLC

FDA 510(k) clearance K211079 for BioFire COVID-19 Test 2, Substantially Equivalent on 2021-11-01. Applicant: Biofire Defense, LLC.

Clearance details

Applicant: Biofire Defense, LLC
Product code: Code QQX
Advisory panel: Microbiology
Date received: 2021-04-12
Decision date: 2021-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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