T2Candida 1.1 Panel

Candida Species Nucleic Acid Detection System

T2 Biosystems, Inc.

The following data is part of a premarket notification filed by T2 Biosystems, Inc. with the FDA for T2candida 1.1 Panel.

Pre-market Notification Details

Device IDK173536
510k NumberK173536
Device Name:T2Candida 1.1 Panel
ClassificationCandida Species Nucleic Acid Detection System
Applicant T2 Biosystems, Inc. 101 Hartwell Avenue Lexington,  MA  02421
ContactAnne Marie Whalen
CorrespondentAnne Marie Whalen
T2 Biosystems, Inc. 101 Hartwell Avenue Lexington,  MA  02421
Product CodePII  
CFR Regulation Number866.3960 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-15
Decision Date2017-12-12
Summary:summary

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