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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-Lipoprotein, Antigen, Antiserum, Control
510(k) Number K872078
Device Name QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL
Applicant
Solomon Park Research Laboratories
12815 NE 124th St., Suite "I"
Kirkland,  WA  98034
Applicant Contact JOAN CORBETT-CLAPSHA
Correspondent
Solomon Park Research Laboratories
12815 NE 124th St., Suite "I"
Kirkland,  WA  98034
Correspondent Contact JOAN CORBETT-CLAPSHA
Regulation Number866.5580
Classification Product Code
DER  
Date Received05/29/1987
Decision Date 06/18/1987
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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