FDA 510(k) Application Details - K231336

Device Classification Name	More FDA Info for this Device
510(K) Number	K231336
Device Name	T2 Biothreat Panel
Applicant	T2 Biosystems, Inc. 101 Hartwell Avenue Lexington, MA 02421 US Other 510(k) Applications for this Company
Contact	Rachel Gilbert Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2023
Decision Date	09/15/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review