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Sysmex Corp.

FDA 510(k) & PMA Approved Devices — 18 products

Total Devices18
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K012372 SYSMEX UF-50LKM2001-09-28 View
510(k) K992875 SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZERGKZ1999-11-09 View
510(k) K981950 SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500GKL1998-11-03 View
510(k) K981761 SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERGKL1998-08-14 View
510(k) K971736 SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETERGKZ1997-08-26 View
510(k) K964946 SYSMEX CA-1000/SYSMEX CA-5000JPA1997-03-18 View
510(k) K964375 SYSMEX SE/RAM-1GKL1997-03-13 View
510(k) K961054 SYSMEX UF-100LKM1996-10-28 View
510(k) K950508 SYSMEX SF-3000FPK1995-11-03 View
510(k) K945837 SYSMEX(TM) F-820, 520GKZ1995-06-09 View
510(k) K942097 TOA MEDICAL ELECTRONICS CA-5000JPA1995-03-24 View
510(k) K942096 TOA MEDICAL ELECTRONICS CA-1000JPA1995-03-24 View
510(k) K943894 SYSMEX K-4500GKZ1995-02-03 View
510(k) K790029 FLUID, RHEMOX W LYSINGGGK1979-02-26 View
510(k) K790028 DILUENT, CELLENT BLOODGIF1979-02-15 View
510(k) K790030 FLUID, RHEMOX-HB LYSINGGKR1979-02-08 View
510(k) K790027 SHAKER, MODEL SH-510JRQ1979-02-08 View
510(k) K790026 ANALYZER, MODEL CC-720GKL1979-02-08 View
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