T2Bacteria® Panel
FDA 510(k) clearance K233184 · decided 2024-02-08
Clearance details
- K-number
- K233184
- Device name
- T2Bacteria® Panel
- Applicant
- T2biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-28
- Decision date
- 2024-02-08
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- QBX
- Device class
- 2
- Regulation number
- 866.3960
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Lexington, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| T2Bacteria Panel (K172708) | T2biosystems, Inc. | 2018-05-24 |
Recalls involving this device
No recalls on record reference this clearance.