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510(k) K092399

ANTI-MUTATED CITRULLINATED VIMENTIN EIA by Orgentec Diagnostika GmbH — Product Code OQZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 1, 2010
Date Received: August 6, 2009
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Anti-Mutated Citrullinated Vimentin Igg
Device Class: Class II
Regulation Number: 866.5775
Review Panel: IM
Submission Type

For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma.