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Sysmex Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K012372SYSMEX UF-50September 28, 2001
K992875SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZERNovember 9, 1999
K981950SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500November 3, 1998
K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERAugust 14, 1998
K971736SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETERAugust 26, 1997
K964946SYSMEX CA-1000/SYSMEX CA-5000March 18, 1997
K964375SYSMEX SE/RAM-1March 13, 1997
K961054SYSMEX UF-100October 28, 1996
K950508SYSMEX SF-3000November 3, 1995
K945837SYSMEX(TM) F-820, 520June 9, 1995
K942096TOA MEDICAL ELECTRONICS CA-1000March 24, 1995
K942097TOA MEDICAL ELECTRONICS CA-5000March 24, 1995
K943894SYSMEX K-4500February 3, 1995
K790029FLUID, RHEMOX W LYSINGFebruary 26, 1979
K790028DILUENT, CELLENT BLOODFebruary 15, 1979
K790027SHAKER, MODEL SH-510February 8, 1979
K790026ANALYZER, MODEL CC-720February 8, 1979
K790030FLUID, RHEMOX-HB LYSINGFebruary 8, 1979