T2Candida 1.1 Panel
FDA 510(k) clearance K234063 · decided 2024-09-13
Clearance details
- K-number
- K234063
- Device name
- T2Candida 1.1 Panel
- Applicant
- T2biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-12-22
- Decision date
- 2024-09-13
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- PII
- 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 |
|---|---|---|
| T2Candida 1.1 Panel (K173536) | T2biosystems, Inc. | 2017-12-12 |
| T2CANDIDA AND T2DX INSTRUMENT (DEN140019) | T2biosystems, Inc. | 2014-09-22 |
Recalls involving this device
No recalls on record reference this clearance.