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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 K173536
Device Name T2Candida 1.1 Panel
Applicant
T2 Biosystems, Inc.
101 Hartwell Avenue
lexington,  MA  02421
Applicant Contact anne marie whalen
Correspondent
T2 Biosystems, Inc.
101 Hartwell Avenue
lexington,  MA  02421
Correspondent Contact anne marie whalen
Regulation Number866.3960
Classification Product Code
PII  
Date Received11/15/2017
Decision Date 12/12/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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