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510(k) K023807

MODIFICATION TO ALKP by Abbott Laboratories — Product Code CJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 2002
Date Received
November 14, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

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