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510(k) K130141

S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) by Hitachi Chemical Diagnostics, Inc. — Product Code CJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2013
Date Received
January 22, 2013
Clearance Type
Traditional
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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