K162840

Substantially Equivalent

Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5

Applicant: Roche Diagnostics
Product code: MRG
Advisory panel: Clinical Chemistry
Date received: 2016-10-11
Decision date: 2017-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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