LP(A)-LATEX SEIKEN ASSAY KIT— 510(k) K013359

Substantially Equivalent

Denka Seiken'S

FDA 510(k) clearance K013359 for LP(A)-LATEX SEIKEN ASSAY KIT, Substantially Equivalent on 2002-03-08. Applicant: Denka Seiken'S. Device class: 2.

Clearance details

Applicant: Denka Seiken'S
Product code: Code DFC
Device class: Class 2
Regulation: 21 CFR 866.5600
Advisory panel: Immunology
Date received: 2001-10-10
Decision date: 2002-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, 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.