T2CANDIDA AND T2DX INSTRUMENT

Candida Species Nucleic Acid Detection System

T2 BIOSYSTEMS, INC

The following data is part of a De Novo classification by T2 Biosystems, Inc with the FDA for T2candida And T2dx Instrument.

Pre-market Notification Details

DeNovo IDDEN140019
Device Name:T2CANDIDA AND T2DX INSTRUMENT
ClassificationCandida Species Nucleic Acid Detection System
Applicant T2 BIOSYSTEMS, INC 101 Hartwell Ave. Lexington,  MA  02421
ContactSarah Kalil
Product CodePII  
CFR Regulation Number866.3960 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardMicrobiology
Classification AdvisoryMicrobiology
TypeDirect
Date Received2014-05-27
Decision Date2014-09-22
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M70885083760 DEN140019 000
M70885083763 DEN140019 000
M70890017940 DEN140019 000
M70870049330 DEN140019 000
M70880016893 DEN140019 000

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