IMMULITE 2000 ANTI-CCP IGG ASSAY— 510(k) K121576

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K121576 for IMMULITE 2000 ANTI-CCP IGG ASSAY, Substantially Equivalent on 2013-04-04. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: 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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