Sysmex Corp.

Medical device manufacturer in Kobe-shi, Japa.

18510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K012372Sysmex UF-50LKM · Traditional 09/28/2001SE
K992875Sysmex XE-2100, Automatated Hematology AnalyzerGKZ · Traditional 11/09/1999SE
K981950Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500GKL · Traditional 11/03/1998SE
K981761Sysmex KX-21, Automated Hematology AnalyzerGKL · Traditional 08/14/1998SE
K971736Sysmex Immature Reticulocyte Fraction (Irf) ParameterGKZ · Traditional 08/26/1997SE
K964946Sysmex CA-1000/SYSMEX CA-5000JPA · Traditional 03/18/1997SE
K964375Sysmex SE/RAM-1GKL · Traditional 03/13/1997SE
K961054Sysmex UF-100LKM · Traditional 10/28/1996SE
K950508Sysmex SF-3000FPK · Traditional 11/03/1995SE
K945837Sysmex(Tm) F-820, 520GKZ · Traditional 06/09/1995SE
K942097Toa Medical Electronics CA-5000JPA · Traditional 03/24/1995SE
K942096Toa Medical Electronics CA-1000JPA · Traditional 03/24/1995SE
K943894Sysmex K-4500GKZ · Traditional 02/03/1995SE
K790029Fluid, Rhemox W LysingGGK · Traditional 02/26/1979SE
K790028Diluent, Cellent BloodGIF · Traditional 02/15/1979SE
K790030Fluid, Rhemox-Hb LysingGKR · Traditional 02/08/1979SE
K790027Shaker, Model SH-510JRQ · Traditional 02/08/1979SE
K790026Analyzer, Model CC-720GKL · Traditional 02/08/1979SE

Recalls

RecallProductInitiated
Z-1945-2016 Class IIThe XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated…There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values. 12/18/2014Terminated