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BIOFIRE® FILMARRAY® Pneumonia Panel - BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
FDA 510(k)Class II (US FDA 510(k))
510(k) K243222
Identifiers
- 510(k) Number
- K243222 FDA 510(k)
- FDA Product Code
- QDS FDA 510(k)
- Models / Variants
- 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® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) by Biofire Diagnostics, LLC (Biomerieux) — Class…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243222 | Class II | Active |
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Manufacturer
- Manufacturer
- Biofire Diagnostics, LLC (Biomerieux)
Sources (1)
- FDA 510(k) K243222 24 fields · synced Jun 18, 2026