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510(k) K841433

CORNING LACTATE DEHYDROPHORETIC ASSAY by Corning Medical & Scientific — Product Code CFE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1984
Date Received
April 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device Class
Class II
Regulation Number
862.1445
Review Panel
CH
Submission Type

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