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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name alpha-1-lipoprotein, antigen, antiserum, control
510(k) Number K983289
Device Name APOLIPOPROTEIN A1
Applicant
ABBOTT LABORATORIES
DEPT. 09VA LC-2
1920 HURD DRIVE
IRVING,  TX  75038
Applicant Contact LINDA MORRIS
Correspondent
ABBOTT LABORATORIES
DEPT. 09VA LC-2
1920 HURD DRIVE
IRVING,  TX  75038
Correspondent Contact LINDA MORRIS
Regulation Number866.5580
Classification Product Code
DER  
Date Received09/18/1998
Decision Date 01/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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