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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Direct Blood Bacterial Nucleic Acid Detection System
510(k) Number K172708
Device Name T2Bacteria Panel
Applicant
T2biosystems, Inc.
101 Hartwell Ave.
Lexington,  MA  02421
Applicant Contact Tom Lowery
Correspondent
T2biosystems, Inc.
101 Hartwell Ave.
Lexington,  MA  02421
Correspondent Contact Tom Lowery
Regulation Number866.3960
Classification Product Code
QBX  
Subsequent Product Code
NSU  
Date Received09/08/2017
Decision Date 05/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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