FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0— 510(k) K143171
Substantially EquivalentBiofire Diagnostics, LLC
FDA 510(k) clearance K143171 for FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0, Substantially Equivalent on 2015-01-30. Applicant: Biofire Diagnostics, LLC.
Clearance details
- Applicant
- Biofire Diagnostics, LLC
- Product code
- Code PEN
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Adverse events under product code PEN
product code PEN- Death
- 7
- Total
- 7
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.