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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K895914
Device Name ABBOTT IMX IGE
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact JEAN FRYDMAN
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact JEAN FRYDMAN
Regulation Number866.5510
Classification Product Code
DGC  
Date Received10/10/1989
Decision Date 11/13/1989
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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