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510(k) K790257

SYSTEMIC LUPUS by Icl Scientific — Product Code DHC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1979
Date Received
February 6, 1979
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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