510(k) K940004

AI-PHOTODIAGNOSTIC by Pharmarceutical Discovery Corp. — Product Code CIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1995
Date Received
January 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Angiotensin I And Renin
Device Class
Class II
Regulation Number
862.1085
Review Panel
CH
Submission Type