FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch— 510(k) K160457
Substantially EquivalentBiofire Diagnostics, LLC
FDA 510(k) clearance K160457 for FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch, Substantially Equivalent on 2016-03-15. 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
- Special
- 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.