Panels › Microbiology › Product code QDP · Class 2
Respiratory Panel
Regulation 866.3985
0510(k)s in 12 months (2 all time)
1recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in QDP
| Company | 510(k)s | Recalls |
|---|---|---|
| Biofire Diagnostics, LLC | 2 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 13, 2026 | BioFire Diagnostics, LLC Generic Name: FilmArray Pneumonia Panel
Generic Name: FilmArray Pneumonia Panel
Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification k Open, Classified |
QDP | K243222 |
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