FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch— 510(k) K160459
Substantially EquivalentBiofire Diagnostics, LLC
FDA 510(k) clearance K160459 for FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch, Substantially Equivalent on 2016-04-01. Applicant: Biofire Diagnostics, LLC.
Clearance details
- Applicant
- Biofire Diagnostics, LLC
- Product code
- Code PCH
- 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.