BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel— 510(k) K220870

Substantially Equivalent

Biofire Defense, LLC

FDA 510(k) clearance K220870 for BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel, Substantially Equivalent on 2022-10-20. Applicant: Biofire Defense, LLC.

Clearance details

Applicant: Biofire Defense, LLC
Product code: Code QMV
Advisory panel: Microbiology
Date received: 2022-03-25
Decision date: 2022-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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