Elecsys Vitamin D Total III

System, Test, Vitamin D

Roche Diagnostics

The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Vitamin D Total Iii.

Pre-market Notification Details

Device IDK210901
510k NumberK210901
Device Name:Elecsys Vitamin D Total III
ClassificationSystem, Test, Vitamin D
Applicant Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis,  IN  46250
ContactJamie Ferguson
CorrespondentJamie Ferguson
Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis,  IN  46250
Product CodeMRG  
CFR Regulation Number862.1825 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-26
Decision Date2021-09-01

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