HDL-EX SEIKEN ASSAY KIT— 510(k) K041090

Substantially Equivalent

Denka Seiken Co., Ltd.

FDA 510(k) clearance K041090 for HDL-EX SEIKEN ASSAY KIT, Substantially Equivalent on 2004-10-29. Applicant: Denka Seiken Co., Ltd.. Device class: 1.

Clearance details

Applicant: Denka Seiken Co., Ltd.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 2004-04-26
Decision date: 2004-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niigata, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.