Cleared Traditional

Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor

K191562 · HORIBA ABX SAS · Immunology
Mar 2020
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K191562 is an FDA 510(k) clearance for the Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor, a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on March 6, 2020, 267 days after receiving the submission on June 13, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number K191562 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2019
Decision Date March 06, 2020
Days to Decision 267 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DBF — Ferritin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5340

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