BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel— 510(k) K213362
Substantially EquivalentBiofire Defense, LLC
FDA 510(k) clearance K213362 for BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel, Substantially Equivalent on 2023-03-22. Applicant: Biofire Defense, LLC.
Clearance details
- Applicant
- Biofire Defense, LLC
- Product code
- Code QVR
- Advisory panel
- Immunology
- 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.