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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 6 of 6 Results
ProductCode: GKZ Applicant: SYSMEX CORP. Decision Date To: 04/18/2024
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sysmex uf-50 SYSMEX CORP. K012372 09/28/2001
sysmex xe-2100, automatated hematology analyzer SYSMEX CORP. K992875 11/09/1999
sysmex kx-21, automated hematology analyzer SYSMEX CORP. K981761 08/14/1998
sysmex immature reticulocyte fraction (irf) parameter SYSMEX CORP. K971736 08/26/1997
sysmex(tm) f-820, 520 SYSMEX CORP. K945837 06/09/1995
sysmex k-4500 SYSMEX CORP. K943894 02/03/1995
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