510(k) K234063
- Device
- T2Candida 1.1 Panel
- Applicant
- T2biosystems, Inc.
- 510(k) number
- K234063
- Product code
- PII
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-13
- Date received
- 2023-12-22
- Regulation
- 866.3960
- Classification name
- Candida Species Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- 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#
- 3010749841
- 3004613294