510(k) K860311

ACTHK-PR RIA KIT by Compagnie Oris Industrie, S.A. — Product Code CKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1986
Date Received
January 28, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Acth
Device Class
Class II
Regulation Number
862.1025
Review Panel
CH
Submission Type