510(k) K213362
- Device
- BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel
- Applicant
- Biofire Defense, LLC
- 510(k) number
- K213362
- Product code
- QVR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-22
- Date received
- 2021-10-12
- Regulation
- 866.4000
- Classification name
- Multiplex Nucleic Acid Detection System For Biothreat Agents
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Cynthia Phillips
- Address
- 79 W 4500 S Suite 14 Salt Lake City UT US 84107 84107
FDA Registration Numbers#
- 3016838963
- 3010770794
Source Documents#
Other 510(k) Records For Product Code QVR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231336 | T2 Biothreat Panel | T2biosystems, Inc. | 2023-09-15 |