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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipoprotein, Low-Density, Antigen, Antiserum, Control
510(k) Number K021660
Device Name K-ASSAY LP(A) ASSAY
Applicant
Kamiya Biomedical Co.
910 Industry Dr.
Seattle,  WA  98188
Applicant Contact BRIAN SCHLIESMAN
Correspondent
Kamiya Biomedical Co.
910 Industry Dr.
Seattle,  WA  98188
Correspondent Contact BRIAN SCHLIESMAN
Regulation Number866.5600
Classification Product Code
DFC  
Subsequent Product Code
JIS  
Date Received05/20/2002
Decision Date 07/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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