DeviceClearance

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel) +1 more— 510(k) K243222

Substantially Equivalent

Biofire Diagnostics, LLC (Biomerieux)

FDA 510(k) clearance K243222 for BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel) +1 more, Substantially Equivalent on 2024-11-06. Applicant: Biofire Diagnostics, LLC (Biomerieux). Device class: 2.

Clearance details

Device name as filed
BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
Applicant
Biofire Diagnostics, LLC (Biomerieux)
Product code
Code QDS
Device class
Class 2
Regulation
21 CFR 866.4001
Advisory panel
Pathology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Salt Lake City, UT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code QDS

product code QDS
Death
3
Total
3

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

Recalls naming K243222

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K243222.

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