FDA 510(k) Application Details - K173536

Device Classification Name	More FDA Info for this Device
510(K) Number	K173536
Device Name	T2Candida 1.1 Panel
Applicant	T2 Biosystems, Inc. 101 Hartwell Avenue Lexington, MA 02421 US Other 510(k) Applications for this Company
Contact	Anne Marie Whalen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PII Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2017
Decision Date	12/12/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review