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U.S. Department of Health and Human Services

510(k) Premarket Notification

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ProductCode: GKZ Applicant: SYSMEX CORPORATION OF AMERICA Decision Date To: 04/25/2024
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sysmex xt-series, model xt-2000i and xt-1800i SYSMEX CORPORATION OF AMERICA K021241 06/25/2002
hpc (hematopoietic progenitor cell) parameter on the imi channel of the sysmex se-9500 and xe-2100, automated hematology SYSMEX CORPORATION OF AMERICA K020496 04/12/2002
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