K151786

Substantially Equivalent

Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet

Applicant: Roche Diagnostics
Product code: CDD
Advisory panel: Clinical Chemistry
Date received: 2015-07-01
Decision date: 2015-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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