T2Bacteria Panel

Direct Blood Bacterial 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 T2bacteria Panel.

Pre-market Notification Details

Device IDK172708
510k NumberK172708
Device Name:T2Bacteria Panel
ClassificationDirect Blood Bacterial Nucleic Acid Detection System
Applicant T2 Biosystems, Inc. 101 Hartwell Avenue Lexington,  MA  02421
ContactTom Lowery
CorrespondentTom Lowery
T2 Biosystems, Inc. 101 Hartwell Avenue Lexington,  MA  02421
Product CodeQBX  
CFR Regulation Number866.3960 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-08
Decision Date2018-05-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M70890080710 K172708 000
M70880073423 K172708 000
M70885080730 K172708 000
M70880080720 K172708 000

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