FilmArray Respiratory Panel 2 plus (RP2plus)— 510(k) DEN170017

Name: FDA 510(k) clearance DEN170017
Creator: U.S. Food and Drug Administration
Published: 2017-11-24

Unknown

Biofire Diagnostics, LLC

FDA 510(k) clearance DEN170017 for FilmArray Respiratory Panel 2 plus (RP2plus), Unknown on 2017-11-24. Applicant: Biofire Diagnostics, LLC. Device class: 2.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code PZF
Device class: Class 2
Regulation: 21 CFR 866.4001
Advisory panel: Pathology
Date received: 2017-03-16
Decision date: 2017-11-24
Decision: Unknown
Clearance type: Direct
Location: Salt Lake City, UT, US

View on FDA.gov ↗

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