The following data is part of a premarket notification filed by T2 Biosystems, Inc. with the FDA for T2candida 1.1 Panel.
| Device ID | K173536 |
| 510k Number | K173536 |
| Device Name: | T2Candida 1.1 Panel |
| Classification | Candida Species Nucleic Acid Detection System |
| Applicant | T2 Biosystems, Inc. 101 Hartwell Avenue Lexington, MA 02421 |
| Contact | Anne Marie Whalen |
| Correspondent | Anne Marie Whalen T2 Biosystems, Inc. 101 Hartwell Avenue Lexington, MA 02421 |
| Product Code | PII |
| CFR Regulation Number | 866.3960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-15 |
| Decision Date | 2017-12-12 |
| Summary: | summary |