FilmArray Respiratory Panel EZ (RP EZ)— 510(k) K152579

Substantially Equivalent

Biofire Diagnostics, LLC

FDA 510(k) clearance K152579 for FilmArray Respiratory Panel EZ (RP EZ), Substantially Equivalent on 2016-10-03. Applicant: Biofire Diagnostics, LLC.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2015-09-10
Decision date: 2016-10-03
Decision: Substantially Equivalent
Clearance type: Dual Track
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.