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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K083579
Device Name DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
Applicant
Siemens Healthcare Diagnostics
Ms 514, P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact VICTOR M CARRIO
Correspondent
Siemens Healthcare Diagnostics
Ms 514, P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact VICTOR M CARRIO
Regulation Number862.1150
Classification Product Code
JIX  
Date Received12/04/2008
Decision Date 02/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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