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510(k) K921578

TITAN GEL ALKALINE PHOSPHATASE (HR) by Helena Laboratories — Product Code CIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1992
Date Received
April 2, 1992
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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