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BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel) +1 more model

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243222

by Biofire Diagnostics, LLC (Biomerieux)

Identifiers

510(k) Number
K243222 FDA 510(k)
FDA Product Code
QDS FDA 510(k)
Models / Variants
BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel) FDA 510(k)
BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.4001 FDA 510(k)
Regulation Number
866.4001 FDA 510(k)
Advisory Committee
Pathology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel) +1 more model by Biofire Diagnostics, LLC (Biomerieux) — Class II — FDA_510K — listed in FDA…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biofire Diagnostics, LLC (Biomerieux)

Sources (1)

  • FDA 510(k) K243222 24 fields · synced Jun 18, 2026