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

Name: FDA 510(k) clearance K160915
Creator: U.S. Food and Drug Administration
Published: 2016-12-14

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K160915 for Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker, Substantially Equivalent on 2016-12-14. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code OVK
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2016-04-01
Decision date: 2016-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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