BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)— 510(k) K243222

Substantially Equivalent

Biofire Diagnostics, LLC (Biomerieux)

FDA 510(k) clearance K243222 for BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus), Substantially Equivalent on 2024-11-06. Applicant: Biofire Diagnostics, LLC (Biomerieux).

Clearance details

Applicant: Biofire Diagnostics, LLC (Biomerieux)
Product code: Code QDS
Advisory panel: Pathology
Date received: 2024-10-07
Decision date: 2024-11-06
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.