K112624

Substantially Equivalent

ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5

Applicant: Roche Diagnostics
Product code: OIU
Advisory panel: Immunology
Date received: 2011-09-08
Decision date: 2012-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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