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510(k) K880344

IQ ALKALINE PHOSPHATASE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code CJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1988
Date Received
January 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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