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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 K862019
Device Name ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT
Applicant
BECKMAN INSTRUMENTS, INC.
2500 HARBOR BLVD.
P.O. BOX 3100
FULLERTON,  CA  92634
Applicant Contact JACK E SOROKIN
Correspondent
BECKMAN INSTRUMENTS, INC.
2500 HARBOR BLVD.
P.O. BOX 3100
FULLERTON,  CA  92634
Correspondent Contact JACK E SOROKIN
Regulation Number862.1475
Classification Product Code
MSJ  
Date Received05/28/1986
Decision Date 07/18/1986
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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