510(k) DEN140019 ยท PII Candida Species Nucleic Acid Detection System
T2CANDIDA AND T2DX INSTRUMENT
| Applicant | T2biosystems, Inc., Lexington MA, US |
| Decision | Unknown, Sep 22, 2014 |
| Received | May 27, 2014 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN140019
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.