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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 K233184
Device Name T2Bacteria® Panel
Applicant
T2 Biosystems, Inc.
101 Hartwell Avenue
Lexington,  MA  02421
Applicant Contact Rachel Gilbert
Correspondent
T2 Biosystems, Inc.
101 Hartwell Avenue
Lexington,  MA  02421
Correspondent Contact Rachel Gilbert
Regulation Number866.3960
Classification Product Code
QBX  
Subsequent Product Code
NSU  
Date Received09/28/2023
Decision Date 02/08/2024
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
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