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510(k) K092736

EUROIMMUN ANTI-M2-3E ELISA (IGG) by Euroimmun Us, Inc. — Product Code DBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2010
Date Received
September 4, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5090
Review Panel
IM
Submission Type

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