Cleared Traditional

Yumizen H2500

K232946 · HORIBA ABX SAS · Hematology
May 2024
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K232946 is an FDA 510(k) clearance for the Yumizen H2500, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on May 21, 2024, 244 days after receiving the submission on September 20, 2023. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K232946 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2023
Decision Date May 21, 2024
Days to Decision 244 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220