Cleared Traditional

Yumizen C1200 CRP

K192028 · HORIBA ABX SAS · Immunology
Jun 2020
Decision
335d
Days
Class 2
Risk

About This 510(k) Submission

K192028 is an FDA 510(k) clearance for the Yumizen C1200 CRP, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on June 25, 2020, 335 days after receiving the submission on July 26, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K192028 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2019
Decision Date June 25, 2020
Days to Decision 335 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DCK — C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

Similar Devices — DCK C-reactive Protein, Antigen, Antiserum, And Control

All 125
K-ASSAY CRP (Ver.2)
K242170 · Kamiya Biomedical Company, LLC · Apr 2025
Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
K201256 · Procise Diagnostics · Nov 2022
CRP Vario
K192118 · SENTINEL CH. SpA · Nov 2019
Yumizen C1200 CRP
K191993 · HORIBA ABX SAS · Oct 2019
VITROS Chemistry Products hsCRP Reagent
K160712 · Ortho-Clinical Diagnostics · Jul 2017
QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
K142993 · Orion Diagnostica, OY · Mar 2016