510(k) K212727
- Device
- FilmArray Pneumonia Panel
- Applicant
- BioFire Diagnostics, LLC
- 510(k) number
- K212727
- Product code
- QDP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-09-22
- Date received
- 2021-08-27
- Regulation
- 866.3985
- Classification name
- Respiratory Panel
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kevin Bourzac
- Address
- 515 Colorow Dr. Salt Lake City UT US 84108 84108
FDA Registration Numbers#
- 3002773840
Source Documents#
Other 510(k) Records For Product Code QDP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K180966 | FilmArray Pneumonia Panel | Biofire Diagnostics, LLC | 2018-11-09 |
Legacy Summary#
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FDA Review#
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