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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 K132801
Device Name IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
New York,  NY  10591
Applicant Contact Ernest Joseph
Correspondent
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact Ernest Joseph
Regulation Number866.5750
Classification Product Code
DHB  
Date Received09/13/2013
Decision Date 05/28/2014
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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