BioFire Joint Infection (JI) Panel— 510(k) DEN200066

Unknown

Biofire Diagnostics, LLC

FDA 510(k) clearance DEN200066 for BioFire Joint Infection (JI) Panel, Unknown on 2022-04-29. Applicant: Biofire Diagnostics, LLC.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code QSN
Advisory panel: Microbiology
Date received: 2020-10-27
Decision date: 2022-04-29
Decision: Unknown
Clearance type: Direct
Location: Salt Lake City, UT, US

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