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510(k) K131185

ANA SCREEN ELISA (IGG) by Euroimmun US — Product Code LJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2013
Date Received
April 26, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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