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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Radioallergosorbent (Rast) Immunological
510(k) Number K100910
Device Name IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
Applicant
Siemens Medical Solutions Diagnostics
5210 Pacific Concourse Dr.
Los Angeles,  CA  90045 -6900
Applicant Contact DONNA VELASQUEZ
Correspondent
Siemens Medical Solutions Diagnostics
5210 Pacific Concourse Dr.
Los Angeles,  CA  90045 -6900
Correspondent Contact DONNA VELASQUEZ
Regulation Number866.5750
Classification Product Code
DHB  
Date Received04/01/2010
Decision Date 05/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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