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510(k) K830118

ALKALINE PHOSPHATES ISOENZYME SUBSTRATE by Corning Medical & Scientific — Product Code CIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1983
Date Received
January 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

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