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510(k) K020625

SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 by Helena Laboratories — Product Code CIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2002
Date Received
February 26, 2002
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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