FDA 510(k) Applications for Medical Device Product Code "QDS"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K181324 | BioFire Diagnostics, LLC | FilmArray Pneumonia Panel plus | 11/15/2018 |
| K222601 | BioFire Diagnostics, LLC | FilmArray Pneumonia Panel plus | 10/27/2022 |
| K243222 | BioFire Diagnostics, LLC (bioMerieux) | BIOFIRE« FILMARRAY« Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE« FILMARRAY« Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) | 11/06/2024 |
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