K041090

Substantially Equivalent

HDL-EX SEIKEN ASSAY KIT

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

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