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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 K885269
Device Name ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS
Applicant
Dexall Biomedical Labs, Inc.
145-4 Professional Dr.
Gaithersburg,  MD  20879
Applicant Contact T HUBSCHER
Correspondent
Dexall Biomedical Labs, Inc.
145-4 Professional Dr.
Gaithersburg,  MD  20879
Correspondent Contact T HUBSCHER
Regulation Number866.5750
Classification Product Code
DHB  
Date Received12/22/1988
Decision Date 02/07/1989
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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