BioFire Global Fever Special Pathogens Panel +1 more— 510(k) K213362

Name: FDA 510(k) clearance K213362
Creator: U.S. Food and Drug Administration
Published: 2023-03-22

Substantially Equivalent

Biofire Defense, LLC

FDA 510(k) clearance K213362 for BioFire Global Fever Special Pathogens Panel +1 more, Substantially Equivalent on 2023-03-22. Applicant: Biofire Defense, LLC. Device class: 2.

Clearance details

Device name as filed: BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel
Applicant: Biofire Defense, LLC
Product code: Code QVR
Device class: Class 2
Regulation: 21 CFR 866.4000
Advisory panel: Immunology
Date received: 2021-10-12
Decision date: 2023-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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More clearances from Biofire Defense, LLC

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K261475 — BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit2026-07-17
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K220870 — BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel2022-10-20
K221460 — BioFire COVID-19 Test 22022-07-25
K211079 — BioFire COVID-19 Test 22021-11-01

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