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

Name: FDA 510(k) clearance K220870
Creator: U.S. Food and Drug Administration
Published: 2022-10-20

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. 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: 2022-03-25
Decision date: 2022-10-20
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.