Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M— 510(k) K193525

Name: FDA 510(k) clearance K193525
Creator: U.S. Food and Drug Administration
Published: 2020-06-26

Substantially Equivalent

HORIBA ABX SAS

FDA 510(k) clearance K193525 for Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M, Substantially Equivalent on 2020-06-26. Applicant: HORIBA ABX SAS. Device class: 2.

Clearance details

Applicant: HORIBA ABX SAS
Product code: Code CZP
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2019-12-19
Decision date: 2020-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montpellier Cedex 4, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code CZP

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K993927 — WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD2000-01-14
K983359 — IGA1998-11-04

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