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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K110169
Device Name DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
Applicant
Siemens Healthcare Diagnostics
500 Gbc Dr.
Ms 514
Newark,  DE  19702
Applicant Contact KATHLEEN ANN DRAY-LYONS
Correspondent
Siemens Healthcare Diagnostics
500 Gbc Dr.
Ms 514
Newark,  DE  19702
Correspondent Contact KATHLEEN ANN DRAY-LYONS
Regulation Number862.1150
Classification Product Code
JIT  
Subsequent Product Code
JJX  
Date Received01/20/2011
Decision Date 04/07/2011
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
Predetermined Change
Control Plan Authorized		 No
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