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510(k) K912603

REP ALP-15, 8, & 4 KITS by Helena Laboratories — Product Code CIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1991
Date Received
June 10, 1991
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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