510(k) K232954— BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

Substantially Equivalent

Biofire Diagnostics, LLC

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code QOF
Advisory panel: Microbiology
Date received: 2023-09-21
Decision date: 2024-03-26
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Salt Lake City, UT, US

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