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510(k) K041102

IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA by Immco Diagnostics, Inc. — Product Code LJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2004
Date Received
April 27, 2004
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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