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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prealbumin, Fitc, Antigen, Antiserum, Control
510(k) Number K854811
Device Name ICS PAB PREALBUMIN 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 Number866.5060
Classification Product Code
DDS  
Date Received12/03/1985
Decision Date 01/24/1986
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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