Tetraone System for Epics Xl Flow Cytometry Systems and Cyto-Stat Tertrachrome CD45-Fitc/CD4-Rdi/CD8-Ecd/CD3-PC5

• • Terminated Z-0472-2019 FDA Class I ·initiated 12 Jan 2018

  A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application.

510(k) Number

K963263 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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