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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K841642
Device Name MAST LUMINESCENT ALLERGY SYS
Applicant
Mast Immunosystems
MD 
Correspondent
Mast Immunosystems
MD 
Regulation Number866.5510
Classification Product Code
DGC  
Date Received04/20/1984
Decision Date 06/07/1984
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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