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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Candida Species Nucleic Acid Detection System
510(k) Number K234063
Device Name T2Candida 1.1 Panel
Applicant
T2Biosystems, Inc.
101 Hartwell Avenue
Lexington,  MA  02421
Applicant Contact Rachel Gilbert
Correspondent
T2Biosystems, Inc.
101 Hartwell Avenue
Lexington,  MA  02421
Correspondent Contact Rachel Gilbert
Regulation Number866.3960
Classification Product Code
PII  
Date Received12/22/2023
Decision Date 09/13/2024
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
Predetermined Change
Control Plan Authorized		 No
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