K233184
- 510(k) number
- K233184
- Device name
- T2Bacteria® Panel
- Applicant
- T2biosystems, Inc. MA · US
- Product code
- QBX — Direct Blood Bacterial Nucleic Acid Detection System
- Decision date
- 2024-02-08
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K233184.pdf
Official FDA record: K233184
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.