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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Low Density, Lipoprotein
510(k) Number K043264
Device Name LDL-EX SEIKEN ASSAY KIT
Applicant
Denka Seiken Co., Ltd.
1-2-2, Minami Hon Cho
Gosen-Shi, Niigata,  JP 959-1695
Applicant Contact TOSHIMI MATSUNAGA
Correspondent
Denka Seiken Co., Ltd.
1-2-2, Minami Hon Cho
Gosen-Shi, Niigata,  JP 959-1695
Correspondent Contact TOSHIMI MATSUNAGA
Regulation Number862.1475
Classification Product Code
MRR  
Date Received11/24/2004
Decision Date 01/26/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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