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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Lipoproteins
510(k) Number K081300
Device Name DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
Applicant
Siemens Healthcare Diagnostics
Ms 514, P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact PAMELA A JURGA
Correspondent
Siemens Healthcare Diagnostics
Ms 514, P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact PAMELA A JURGA
Regulation Number862.1475
Classification Product Code
JHM  
Date Received05/08/2008
Decision Date 07/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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