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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 K051677
Device Name OPTIGEN ALLERGEN SPECIFIC IGE ASSAY
Applicant
HITACHI CHEMICAL DIAGNOSTICS, INC.
630 CLYDE CT.
MOUNTAIN VIEW,  CA  94043
Applicant Contact EMI ZYCHLINSKY
Correspondent
HITACHI CHEMICAL DIAGNOSTICS, INC.
630 CLYDE CT.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact EMI ZYCHLINSKY
Regulation Number866.5750
Classification Product Code
DHB  
Subsequent Product Code
DGC  
Date Received06/21/2005
Decision Date 01/23/2006
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
Recalls CDRH Recalls
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