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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 K924044
Device Name VENTREX ALLERGEN DISC
Applicant
Hycor Biomedical, Inc.
217 Read St.
Portland,  ME  04103
Applicant Contact Anne Jepson
Correspondent
Hycor Biomedical, Inc.
217 Read St.
Portland,  ME  04103
Correspondent Contact Anne Jepson
Regulation Number866.5750
Classification Product Code
DHB  
Date Received08/11/1992
Decision Date 12/01/1992
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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