BioFire Respiratory Panel 2.1 (RP2.1)— 510(k) DEN200031

Name: FDA 510(k) clearance DEN200031
Creator: U.S. Food and Drug Administration
Published: 2021-03-17

Unknown

Biofire Diagnostics, LLC

FDA 510(k) clearance DEN200031 for BioFire Respiratory Panel 2.1 (RP2.1), Unknown on 2021-03-17. Applicant: Biofire Diagnostics, LLC. Device class: 2.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2020-05-19
Decision date: 2021-03-17
Decision: Unknown
Clearance type: Direct
Location: Salt Lake City, UT, US

View on FDA.gov ↗

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