K043264

Substantially Equivalent

LDL-EX SEIKEN ASSAY KIT

Applicant: Denka Seiken Co., Ltd.
Product code: MRR
Advisory panel: Clinical Chemistry
Date received: 2004-11-24
Decision date: 2005-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gosen-Shi, Niigata, JP

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