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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 K910075
Device Name SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Applicant Contact KENNETH ASARCH
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Correspondent Contact KENNETH ASARCH
Regulation Number866.5750
Classification Product Code
DHB  
Date Received01/08/1991
Decision Date 01/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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