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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Iga, Antigen, Antiserum, Control
510(k) Number K983359
Device Name IGA
Applicant
Abbott Laboratories
Dept. 09va Lc-2
1920 Hurd Dr.
Irving,  TX  75038
Applicant Contact LINDA MORRIS
Correspondent
Abbott Laboratories
Dept. 09va Lc-2
1920 Hurd Dr.
Irving,  TX  75038
Correspondent Contact LINDA MORRIS
Regulation Number866.5510
Classification Product Code
CZP  
Date Received09/24/1998
Decision Date 11/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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