FDA 510(k) Application Details - DEN140019

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN140019
Device Name	T2CANDIDA AND T2DX INSTRUMENT
Applicant	T2 BIOSYSTEMS, INC 101 Hartwell Ave. Lexington, MA 02421 US Other 510(k) Applications for this Company
Contact	Sarah Kalil 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	05/27/2014
Decision Date	09/22/2014
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review