K234063
- 510(k) number
- K234063
- Device name
- T2Candida 1.1 Panel
- Applicant
- T2biosystems, Inc. MA · US
- Product code
- PII — Candida Species Nucleic Acid Detection System
- Decision date
- 2024-09-13
- Date received
- 2023-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K234063.pdf
Official FDA record: K234063
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.