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510(k) K061408

EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT by Euroimmun Us, LLC — Product Code MVM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2006
Date Received
May 22, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Autoantibodies, Endomysial(Tissue Transglutaminase)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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