BIOFIRE FILMARRAY Tropical Fever Panel— 510(k) K243463

Name: FDA 510(k) clearance K243463
Creator: U.S. Food and Drug Administration
Published: 2024-12-05

Substantially Equivalent

Biofire Diagnostics, LLC (Biomerieux)

FDA 510(k) clearance K243463 for BIOFIRE FILMARRAY Tropical Fever Panel, Substantially Equivalent on 2024-12-05. Applicant: Biofire Diagnostics, LLC (Biomerieux). Device class: 2.

Clearance details

Applicant: Biofire Diagnostics, LLC (Biomerieux)
Product code: Code QMV
Device class: Class 2
Regulation: 21 CFR 866.3966
Advisory panel: Microbiology
Date received: 2024-11-08
Decision date: 2024-12-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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