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510(k) K131330

GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT by Gold Standard Diagnostics — Product Code LJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2014
Date Received
May 8, 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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