Cleared Traditional

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M

K193525 · HORIBA ABX SAS · Immunology

Jun 2020

Decision

190d

Days

Class 2

Risk

About This 510(k) Submission

K193525 is an FDA 510(k) clearance for the Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M, a Iga, Antigen, Antiserum, Control (Class II — Special Controls, product code CZP), submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on June 26, 2020, 190 days after receiving the submission on December 19, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number	K193525 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2019
Decision Date	June 26, 2020
Days to Decision	190 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF