Elecsys Anti-TSHR

System, Test, Thyroid Autoantibody

Roche Diagnostics

The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Anti-tshr.

Pre-market Notification Details

Device IDK193313
510k NumberK193313
Device Name:Elecsys Anti-TSHR
ClassificationSystem, Test, Thyroid Autoantibody
Applicant Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46256
ContactReanna Toney
CorrespondentReanna Toney
Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46256
Product CodeJZO  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyImmunology
510k Review PanelImmunology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-29
Decision Date2020-02-27

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