K121576

Substantially Equivalent

IMMULITE 2000 ANTI-CCP IGG ASSAY

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: NHX
Advisory panel: Immunology
Date received: 2012-05-30
Decision date: 2013-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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