FilmArray Pneumonia Panel plus— 510(k) K181324
Substantially EquivalentBiofire Diagnostics, LLC
FDA 510(k) clearance K181324 for FilmArray Pneumonia Panel plus, Substantially Equivalent on 2018-11-15. Applicant: Biofire Diagnostics, LLC.
Clearance details
- Applicant
- Biofire Diagnostics, LLC
- Product code
- Code QDS
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Adverse events under product code QDS
product code QDS- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.