BIOFIRE SPOTFIRE Respiratory (R) Panel— 510(k) K213954

Substantially Equivalent

Biofire Diagnostics

FDA 510(k) clearance K213954 for BIOFIRE SPOTFIRE Respiratory (R) Panel, Substantially Equivalent on 2023-02-03. Applicant: Biofire Diagnostics.

Clearance details

Applicant: Biofire Diagnostics
Product code: Code QOF
Advisory panel: Microbiology
Date received: 2021-12-17
Decision date: 2023-02-03
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Salt Lake City, UT, US

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