Multiset Software for Automated Flow Cytometric Data Analysis

• • Terminated Z-0570-2008 FDA Unclassified (pre-2012) ·initiated 6 Sep 2007

  Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without using the Manual Gate function (as described in the system manual), the statistic results will not be updated to match the adjusted gate.

510(k) Number

K963963 ↗

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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