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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipoprotein X, Antigen, Antiserum, Control
510(k) Number K900124
Device Name APOLIPOPROTEIN B (APO B)
Applicant
Sigma Chemical Co.
545 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact MATHEW MADAPPALLY
Correspondent
Sigma Chemical Co.
545 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact MATHEW MADAPPALLY
Regulation Number866.5590
Classification Product Code
DEL  
Date Received01/09/1990
Decision Date 03/02/1990
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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