LDL-EX SEIKEN ASSAY KIT— 510(k) K043264

Substantially Equivalent

Denka Seiken Co., Ltd.

FDA 510(k) clearance K043264 for LDL-EX SEIKEN ASSAY KIT, Substantially Equivalent on 2005-01-26. Applicant: Denka Seiken Co., Ltd..

Clearance details

Applicant: Denka Seiken Co., Ltd.
Product code: 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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