510(k) K791096

RADIOIMMUNOASSAY TEST SYSTEM by Corning Medical & Scientific — Product Code JMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1979
Date Received
June 12, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay (Two-Site Solid Phase), Ferritin
Device Class
Class II
Regulation Number
866.5340
Review Panel
CH
Submission Type