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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 K965094
Device Name HYCOR ALLERGEN DISC
Applicant
Hycor Biomedical, Inc.
7272 Chapman Ave.
Garden Grove,  CA  92841
Applicant Contact M. ALEM, PH.D.
Correspondent
Hycor Biomedical, Inc.
7272 Chapman Ave.
Garden Grove,  CA  92841
Correspondent Contact M. ALEM, PH.D.
Regulation Number866.5750
Classification Product Code
DHB  
Date Received12/19/1996
Decision Date 05/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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