FilmArray Pneumonia Panel— 510(k) K212727
Substantially EquivalentBiofire Diagnostics, LLC
FDA 510(k) clearance K212727 for FilmArray Pneumonia Panel, Substantially Equivalent on 2021-09-22. Applicant: Biofire Diagnostics, LLC.
Clearance details
- Applicant
- Biofire Diagnostics, LLC
- Product code
- Code QDP
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake City, UT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.