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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 K030590
Device Name CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)
Applicant
Hitachi Chemical Diagnostics, Inc.
630 Clyde Ct.
Mountain View,  CA  94043
Applicant Contact MARY ANN DU BROCK
Correspondent
Hitachi Chemical Diagnostics, Inc.
630 Clyde Ct.
Mountain View,  CA  94043
Correspondent Contact MARY ANN DU BROCK
Regulation Number866.5750
Classification Product Code
DHB  
Date Received02/25/2003
Decision Date 03/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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