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 |
M70880016893 | DEN140019 | 000 |