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 |