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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apolipoproteins
510(k) Number K850690
Device Name ANTISERUM TO HUMAN APOLIPOPROTEIN B
Applicant
Kent Laboratories, Inc.
23404 NE 8th St.
Redmond,  WA  98053
Applicant Contact ALLAN H JORGENSEN
Correspondent
Kent Laboratories, Inc.
23404 NE 8th St.
Redmond,  WA  98053
Correspondent Contact ALLAN H JORGENSEN
Regulation Number862.1475
Classification Product Code
MSJ  
Date Received02/21/1985
Decision Date 11/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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