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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 K083462
Device Name DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350
Applicant
Siemens Healthcare Diagnostics
500 Gbc Dr.,
M/S 514
Newark,  DE  19714
Applicant Contact HELEN M LEE
Correspondent
Siemens Healthcare Diagnostics
500 Gbc Dr.,
M/S 514
Newark,  DE  19714
Correspondent Contact HELEN M LEE
Regulation Number862.1150
Classification Product Code
JIT  
Date Received11/24/2008
Decision Date 02/27/2009
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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