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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name alpha-naphthyl phosphate, alkaline phosphatase or isoenzymes
510(k) Number K122323
Device Name DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI
Original Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
500 gbc drive
ms 514
newark,  DE  19702
Original Contact rose t marinelli
Regulation Number862.1050
Classification Product Code
CJO  
Subsequent Product Code
JIT  
Date Received08/01/2012
Decision Date 08/28/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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