CCPOINT— 510(k) K093908

Substantially Equivalent

Euro-Diagnostica AB

FDA 510(k) clearance K093908 for CCPOINT, Substantially Equivalent on 2010-12-01. Applicant: Euro-Diagnostica AB.

Clearance details

Applicant: Euro-Diagnostica AB
Product code: Code NHX
Advisory panel: Immunology
Date received: 2009-12-22
Decision date: 2010-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Cadwell, NJ, US

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