BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini— 510(k) K243544

Substantially Equivalent

Biofire Diagnostics, LLC

FDA 510(k) clearance K243544 for BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini, Substantially Equivalent on 2025-08-14. Applicant: Biofire Diagnostics, LLC.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code QOF
Advisory panel: Microbiology
Date received: 2024-11-15
Decision date: 2025-08-14
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Salt Lake City, UT, US

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