Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor— 510(k) K191562

Name: FDA 510(k) clearance K191562
Creator: U.S. Food and Drug Administration
Published: 2020-03-06

Substantially Equivalent

HORIBA ABX SAS

FDA 510(k) clearance K191562 for Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor, Substantially Equivalent on 2020-03-06. Applicant: HORIBA ABX SAS. Device class: 2.

Clearance details

Applicant: HORIBA ABX SAS
Product code: Code DBF
Device class: Class 2
Regulation: 21 CFR 866.5340
Advisory panel: Immunology
Date received: 2019-06-13
Decision date: 2020-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montpellier Cedex 4, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code DBF

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K193650 — LIAISON Ferritin2021-09-14
K171642 — Atellica IM Ferritin Assay2017-08-31
K133083 — DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET2014-06-24
K121232 — K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR2012-05-24
K110736 — ADVIA CHEMISTRY FERRITIN (FRT) METHOD2011-08-17

More clearances from HORIBA ABX SAS

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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
K192028 — Yumizen C1200 CRP2020-06-25
K191993 — Yumizen C1200 CRP2019-10-03

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