FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System— 510(k) K143080

Substantially Equivalent

Biofire Diagnostics, LLC

FDA 510(k) clearance K143080 for FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System, Substantially Equivalent on 2015-02-17. Applicant: Biofire Diagnostics, LLC.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2014-10-27
Decision date: 2015-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.