K231336
- 510(k) number
- K231336
- Device name
- T2 Biothreat Panel
- Applicant
- T2biosystems, Inc. MA · US
- Product code
- QVR — Multiplex Nucleic Acid Detection System For Biothrea
- Decision date
- 2023-09-15
- Date received
- 2023-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K231336.pdf
Official FDA record: K231336
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.