510(k) K840462

VITAMIN B12 57CO/FOLATE 125I - by Corning Medical & Scientific — Product Code CDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1984
Date Received
February 2, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Vitamin B12
Device Class
Class II
Regulation Number
862.1810
Review Panel
CH
Submission Type