FilmArray Pneumonia Panel plus— 510(k) K222601

Substantially Equivalent

Biofire Diagnostics, LLC

FDA 510(k) clearance K222601 for FilmArray Pneumonia Panel plus, Substantially Equivalent on 2022-10-27. Applicant: Biofire Diagnostics, LLC.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code QDS
Advisory panel: Pathology
Date received: 2022-08-29
Decision date: 2022-10-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QDS

product code QDS

Death: 3
Total: 3

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.