510(k) K800991

CORDIA N by Cordis Corp. — Product Code DHC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1980
Date Received
April 24, 1980
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