FDA 510(k) Application Details - K172708

Device Classification Name	More FDA Info for this Device
510(K) Number	K172708
Device Name	T2Bacteria Panel
Applicant	T2 Biosystems, Inc. 101 Hartwell Avenue Lexington, MA 02421 US Other 510(k) Applications for this Company
Contact	Tom Lowery Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2017
Decision Date	05/24/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review