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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Specific
510(k) Number K082030
Device Name DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
Applicant
Siemens Healthcare Diagnostics, Inc.
P.O. Box 6101
Newark,  DE  19714
Applicant Contact YUK-TING LEWIS
Correspondent
Siemens Healthcare Diagnostics, Inc.
P.O. Box 6101
Newark,  DE  19714
Correspondent Contact YUK-TING LEWIS
Regulation Number862.3200
Classification Product Code
DLJ  
Date Received07/17/2008
Decision Date 08/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
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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