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510(k) K930247

HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE by The Binding Site, Ltd. — Product Code DHC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1993
Date Received
January 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Systemic Lupus Erythematosus
Device Class
Class II
Regulation Number
866.5820
Review Panel
IM
Submission Type

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