510(k) K243544

Device: BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
Applicant: Biofire Diagnostics, LLC
510(k) number: K243544
Product code: QOF
Decision: Substantially Equivalent (SESE)
Decision date: 2025-08-14
Date received: 2024-11-15
Regulation: 866.3981
Classification name: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 2
Clearance type: Dual Track
Statement or summary: Summary
Third party reviewed: N

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