BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini— 510(k) K241194

Substantially Equivalent

Biofire Diagnostics, LLC

FDA 510(k) clearance K241194 for BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini, Substantially Equivalent on 2024-05-30. Applicant: Biofire Diagnostics, LLC.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code QOF
Advisory panel: Microbiology
Date received: 2024-04-30
Decision date: 2024-05-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

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