T2 Biothreat Panel
FDA 510(k) clearance K231336 · decided 2023-09-15
Clearance details
- K-number
- K231336
- Device name
- T2 Biothreat Panel
- Applicant
- T2biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-05-08
- Decision date
- 2023-09-15
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- QVR
- Device class
- 2
- Regulation number
- 866.4000
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Lexington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.