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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 K914850
Device Name CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE
Applicant
Mast Immunosystems
630 Clyde Ct.
Mountain View,  CA  94043
Applicant Contact ALEX MONTE
Correspondent
Mast Immunosystems
630 Clyde Ct.
Mountain View,  CA  94043
Correspondent Contact ALEX MONTE
Regulation Number866.5750
Classification Product Code
DHB  
Date Received10/28/1991
Decision Date 12/09/1991
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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