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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 K913150
Device Name ABBOTT MATRIX AERO PLUS SYSTEM
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact CAROL M.COOPER
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact CAROL M.COOPER
Regulation Number866.5750
Classification Product Code
DHB  
Date Received07/16/1991
Decision Date 11/29/1991
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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