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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 K013359
Device Name LP(A)-LATEX SEIKEN ASSAY KIT
Applicant
Denka Seiken'S
3-4-2 Nihonbashi
Kayabacho, Chuo-Ku
Tokyo,  JP 103-0025
Applicant Contact YOUSUKE MEGURO
Correspondent
Denka Seiken'S
3-4-2 Nihonbashi
Kayabacho, Chuo-Ku
Tokyo,  JP 103-0025
Correspondent Contact YOUSUKE MEGURO
Regulation Number866.5600
Classification Product Code
DFC  
Date Received10/10/2001
Decision Date 03/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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