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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name enzymatic method, ammonia
510(k) Number K123677
Device Name DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE M/S 514
NEWARK,  DE  19702
Applicant Contact ROSE T MARINELLI
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE M/S 514
NEWARK,  DE  19702
Correspondent Contact ROSE T MARINELLI
Regulation Number862.1065
Classification Product Code
JIF  
Subsequent Product Code
JIX  
Date Received11/30/2012
Decision Date 03/07/2013
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
Recalls CDRH Recalls
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