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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 K880003
Device Name ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST
Applicant
Em Diagnostic Systems, Inc.
3380 Central Expy.
Santa Clara,  CA  95051
Applicant Contact ALEXANDER MONTE
Correspondent
Em Diagnostic Systems, Inc.
3380 Central Expy.
Santa Clara,  CA  95051
Correspondent Contact ALEXANDER MONTE
Regulation Number866.5750
Classification Product Code
DHB  
Date Received01/04/1988
Decision Date 03/11/1988
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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