Elecsys Troponin T Gen 5

Immunoassay Method, Troponin Subunit

Roche Diagnostics

The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Troponin T Gen 5.

Pre-market Notification Details

Device IDK201441
510k NumberK201441
Device Name:Elecsys Troponin T Gen 5
ClassificationImmunoassay Method, Troponin Subunit
Applicant Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
ContactJane Phillips
CorrespondentJane Phillips
Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
Product CodeMMI  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-01
Decision Date2021-09-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613336158982 K201441 000

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