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510(k) K030929

ANA DETECT by Orgentec Diagnostika GmbH — Product Code LJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2003
Date Received
March 24, 2003
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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