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510(k) K004019

ANA EIA DIAGNOSTIC TEST KIT by The Binding Site, Ltd. — Product Code LJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2001
Date Received
December 27, 2000
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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