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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 22 Results
ProductCode: GKZ Applicant: SYSMEX AMERICA, INC. Decision Date To: 04/25/2024
 
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immature granulocyte (ig) parameter on the sysmex model xe-2100 automated hematology analyzer SYSMEX AMERICA, INC. K032039 09/08/2003
sysmex poch-100i SYSMEX AMERICA, INC. K032677 02/11/2004
sysmex automated hematology analyzer, xe-2100 series (xe-2100, xe-2100l) SYSMEX AMERICA, INC. K040073 03/18/2004
ret-he parameter on the sysmex model xe-2100 automated hematology analyzer SYSMEX AMERICA, INC. K050589 05/04/2005
ipf (immature platelet fraction) parameter on the sysmex model xe-2100 automated hematology analyzer SYSMEX AMERICA, INC. K051199 08/08/2005
sysmex model xe-2100dc automated hematology analyzer SYSMEX AMERICA, INC. K051459 09/23/2005
sysmex automated hematology analyzer models xs series SYSMEX AMERICA, INC. K060656 05/10/2006
sysmex automated hematology analyzer, xt-series SYSMEX AMERICA, INC. K061150 07/06/2006
sysmex xe-5000 SYSMEX AMERICA, INC. K071967 11/20/2007
sysmex model xs-1000ic automated hematology analyzer SYSMEX AMERICA, INC. K081610 08/29/2008
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