K081338

Substantially Equivalent

ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP

Applicant: Roche Diagnostics
Product code: NHX
Advisory panel: Immunology
Date received: 2008-05-13
Decision date: 2008-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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