The following data is part of a De Novo classification by T2 Biosystems, Inc with the FDA for T2candida And T2dx Instrument.
| DeNovo ID | DEN140019 |
| Device Name: | T2CANDIDA AND T2DX INSTRUMENT |
| Classification | Candida Species Nucleic Acid Detection System |
| Applicant | T2 BIOSYSTEMS, INC 101 Hartwell Ave. Lexington, MA 02421 |
| Contact | Sarah Kalil |
| Product Code | PII |
| CFR Regulation Number | 866.3960 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Direct |
| Date Received | 2014-05-27 |
| Decision Date | 2014-09-22 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M70885083760 | DEN140019 | 000 |
| M70885083763 | DEN140019 | 000 |
| M70890017940 | DEN140019 | 000 |
| M70870049330 | DEN140019 | 000 |