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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
Device Name DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
P.O. BOX 6101, MAILSTAP 514
NEWARK,  DE  19714
Applicant Contact ROSE T MARINELLI
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
P.O. BOX 6101, MAILSTAP 514
NEWARK,  DE  19714
Correspondent 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 (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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