IMMUNOSCAN RA ANTI-CCP TEST SYSTEM— 510(k) K052133

Substantially Equivalent

Eurodiagnostica

FDA 510(k) clearance K052133 for IMMUNOSCAN RA ANTI-CCP TEST SYSTEM, Substantially Equivalent on 2005-12-12. Applicant: Eurodiagnostica.

Clearance details

Applicant: Eurodiagnostica
Product code: Code NHX
Advisory panel: Immunology
Date received: 2005-08-05
Decision date: 2005-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frederick, MD, US

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