K230404

Substantially Equivalent

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

Applicant: Biofire Diagnostics, LLC
Product code: PCH
Advisory panel: Microbiology
Date received: 2023-02-15
Decision date: 2023-03-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

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