CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT— 510(k) K011958

Name: FDA 510(k) clearance K011958
Creator: U.S. Food and Drug Administration
Published: 2001-12-04

Substantially Equivalent

Denka Seiken'S

FDA 510(k) clearance K011958 for CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT, Substantially Equivalent on 2001-12-04. Applicant: Denka Seiken'S. Device class: 2.

Clearance details

Applicant: Denka Seiken'S
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2001-06-22
Decision date: 2001-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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