510(k) K810046

CORDIA A by Cordis Corp. — Product Code KHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1981
Date Received
January 12, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Device Class
Class II
Regulation Number
866.3220
Review Panel
MI
Submission Type