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510(k) K083188

VARELISA RECOMBI ANA SCREEN, MODEL 12 596 by Phadia US, Inc. — Product Code LJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2009
Date Received
October 29, 2008
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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  • K041102 — IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA (October 26, 2004)
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