Yumizen C1200 CRP— 510(k) K192028

Substantially Equivalent

HORIBA ABX SAS

FDA 510(k) clearance K192028 for Yumizen C1200 CRP, Substantially Equivalent on 2020-06-25. 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: 2019-07-26
Decision date: 2020-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montpellier Cedex 4, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code DCK

K242170 — K-ASSAY CRP (Ver.2)2025-04-18
K201256 — Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge2022-11-04
K192118 — CRP Vario2019-11-08
K191993 — Yumizen C1200 CRP2019-10-03
K160712 — VITROS Chemistry Products hsCRP Reagent2017-07-14

More clearances from HORIBA ABX SAS

K260781 — Yumizen H5502026-09-14
K232946 — Yumizen H25002024-05-21
K193649 — Yumizen C1200 Creatinine PAP2021-05-10
K193525 — Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M2020-06-26
K191562 — Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor2020-03-06

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