Yumizen C1200 CRP— 510(k) K191993

Substantially Equivalent

HORIBA ABX SAS

FDA 510(k) clearance K191993 for Yumizen C1200 CRP, Substantially Equivalent on 2019-10-03. Applicant: HORIBA ABX SAS. Device class: 2.

Clearance details

Applicant: HORIBA ABX SAS
Product code: Product code DCK
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2019-07-25
Decision date: 2019-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montpellier Cedex 4, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code DCK

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K192118 — CRP Vario2019-11-08
K160712 — VITROS Chemistry Products hsCRP Reagent2017-07-14

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