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510(k) K890269

ALKALINE PHOSPHATASE ISOENZYME REAGENTS by Beckman Instruments, Inc. — Product Code CIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1989
Date Received
January 18, 1989
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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