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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 K851512
Device Name ALLERGENETICS IGE FAST TEST
Applicant
Allergenetics
1500 Salado Dr.
Mountain View,  CA  94043
Applicant Contact YUH-GENG TSAY
Correspondent
Allergenetics
1500 Salado Dr.
Mountain View,  CA  94043
Correspondent Contact YUH-GENG TSAY
Regulation Number866.5750
Classification Product Code
DHB  
Date Received04/15/1985
Decision Date 05/28/1985
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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