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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 K020387
Device Name MYALLERGYTEST SYSTEM
Applicant
Immunetech Corporation
P.O. Box 9433
17394 Via Del Bravo
Rancho Santa Fe,  CA  92067
Applicant Contact VIVIANNE NOETZEL
Correspondent
Immunetech Corporation
P.O. Box 9433
17394 Via Del Bravo
Rancho Santa Fe,  CA  92067
Correspondent Contact VIVIANNE NOETZEL
Regulation Number866.5750
Classification Product Code
DHB  
Date Received02/05/2002
Decision Date 04/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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