510(k) K233184 · QBX Direct Blood Bacterial Nucleic Acid Detection System
T2Bacteria® Panel
| Applicant | T2biosystems, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, Feb 8, 2024 |
| Received | Sep 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233184
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.