510(k) K160915— Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker

Substantially Equivalent

Roche Diagnostics

Clearance details

Applicant: Roche Diagnostics
Product code: Code OVK
Advisory panel: Immunology
Date received: 2016-04-01
Decision date: 2016-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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