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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiplex Nucleic Acid Detection System For Biothreat Agents
510(k) Number K231336
Device Name T2 Biothreat 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
Classification Product Code
QVR  
Subsequent Product Codes
NSU   QBX  
Date Received05/08/2023
Decision Date 09/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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