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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 K121907
Model DF 150, DC150
Device Name DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
Original Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
p.o. box 6101, mailstap 514
newark,  DE  19714
Original Contact rose t marinelli
Regulation Number862.1050
Classification Product Code
CJO  
Subsequent Product Code
JIT  
Date Received06/29/2012
Decision Date 07/23/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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