LDL-EX SEIKEN ASSAY KIT

System, Test, Low Density, Lipoprotein

DENKA SEIKEN CO., LTD.

The following data is part of a premarket notification filed by Denka Seiken Co., Ltd. with the FDA for Ldl-ex Seiken Assay Kit.

Pre-market Notification Details

Device IDK043264
510k NumberK043264
Device Name:LDL-EX SEIKEN ASSAY KIT
ClassificationSystem, Test, Low Density, Lipoprotein
Applicant DENKA SEIKEN CO., LTD. 1-2-2, MINAMIHONCHO Gosen-shi, Niigata,  JP 959-1695
ContactToshimi Matsunaga
CorrespondentToshimi Matsunaga
DENKA SEIKEN CO., LTD. 1-2-2, MINAMIHONCHO Gosen-shi, Niigata,  JP 959-1695
Product CodeMRR  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-24
Decision Date2005-01-26
Summary:summary

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