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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 K090257
Device Name IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Applicant
Siemens Healthcare Diagnostics
511 Benedict Ave.
New York,  NY  10591
Applicant Contact CLARE SANTULLI
Correspondent
Siemens Healthcare Diagnostics
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact CLARE SANTULLI
Regulation Number866.5750
Classification Product Code
DHB  
Date Received02/02/2009
Decision Date 05/26/2009
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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