510(k) K234063 ยท PII Candida Species Nucleic Acid Detection System
T2Candida 1.1 Panel
| Applicant | T2biosystems, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, Sep 13, 2024 |
| Received | Dec 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234063
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.