FILMARRAY GASTROINTESTINAL (GI) PANEL— 510(k) K140407
Substantially EquivalentBiofire Diagnostics
FDA 510(k) clearance K140407 for FILMARRAY GASTROINTESTINAL (GI) PANEL, Substantially Equivalent on 2014-05-02. Applicant: Biofire Diagnostics.
Clearance details
- Applicant
- Biofire Diagnostics
- Product code
- Code PCH
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.