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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 K895160
Device Name ORTHO *APO A-1 ELISA TEST SYSTEM
Applicant
Medical Marketing Consultants, Inc.
3 Bethesda Metro Center
Suite 750
Bethesda,  MD  20814
Applicant Contact JOYCE DAVIS
Correspondent
Medical Marketing Consultants, Inc.
3 Bethesda Metro Center
Suite 750
Bethesda,  MD  20814
Correspondent Contact JOYCE DAVIS
Regulation Number866.5590
Classification Product Code
DEL  
Date Received08/23/1989
Decision Date 10/06/1989
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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