510(k) K231336
- Device
- T2 Biothreat Panel
- Applicant
- T2biosystems, Inc.
- 510(k) number
- K231336
- Product code
- QVR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-15
- Date received
- 2023-05-08
- 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
- Rachel Gilbert
- Address
- 101 Hartwell Ave. Lexington MA US 02421 02421
FDA Registration Numbers#
- 3016838963
- 3010770794
Source Documents#
Other 510(k) Records For Product Code QVR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel | Biofire Defense, LLC | 2023-03-22 |