BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
FDA 510(k) clearance K243222 · decided 2024-11-06
Clearance details
- K-number
- K243222
- Device name
- BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
- Applicant
- Biofire Diagnostics, LLC (Biomerieux)
- Decision
- Substantially Equivalent
- Date received
- 2024-10-07
- Decision date
- 2024-11-06
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- QDS
- Device class
- 2
- Regulation number
- 866.4001
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FilmArray Pneumonia Panel plus (K222601) | Biofire Diagnostics, LLC | 2022-10-27 |
| FilmArray Pneumonia Panel plus (K181324) | Biofire Diagnostics, LLC | 2018-11-15 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 recall (Z-1518-2025) | BioFire Diagnostics, LLC | 2025-04-04 |