FDA Product Code
FDA Product Code QDS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Pathology
- 21 CFR Citation
- 866.4001
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243222 | BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) | Biofire Diagnostics, LLC (Biomerieux) | 2024-11-06 | Special | PDF ↗ |
| K222601 | FilmArray Pneumonia Panel plus | Biofire Diagnostics, LLC | 2022-10-27 | Special | PDF ↗ |
| K181324 | FilmArray Pneumonia Panel plus | Biofire Diagnostics, LLC | 2018-11-15 | Traditional | PDF ↗ |
Product code QDS · Class II · Pathology. Data: openFDA.