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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 22, 2021 | K212727 | FilmArray Pneumonia Panel Biofire Diagnostics, LLC | QDP |
| Nov 9, 2018 | K180966 | FilmArray Pneumonia Panel Biofire Diagnostics, LLC | QDP |
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