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Toa Medical Electronics USA, Inc.

FDA 510(k) & PMA Approved Devices — 33 products

Total Devices33
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K936023 SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZERGKZ1994-05-02 View
510(k) K933886 TOA MEDICAL ELECTRONICS CA-5000JPA1994-01-27 View
510(k) K931149 CA-1000 AUTOMATED COAGULATION ANALYZERJPA1993-11-03 View
510(k) K920544 SYSMEX HEMATOLOGY SYSTEM ACCESSORIESGKZ1992-04-29 View
510(k) K914744 SYSMEX NE-1500, MODIFICATIONGKZ1991-12-30 View
510(k) K912494 SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZERGKL1991-09-10 View
510(k) K910849 SYSMEX F-810GKL1991-07-26 View
510(k) K911172 SYSMEX F-610GKL1991-07-26 View
510(k) K911173 SYSMEX F-310GKL1991-07-26 View
510(k) K910745 HEMOGLOBIN REAGENTGKR1991-07-11 View
510(k) K894539 SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZERGKL1989-09-26 View
510(k) K883997 SYSMEX NE-8000GKZ1988-12-05 View
510(k) K882370 SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZERGKZ1988-08-25 View
510(k) K882767 SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEMGKH1988-07-18 View
510(k) K882267 SYSMEX QUICKLYSER-II (QLS-200A)GIF1988-07-12 View
510(k) K873734 SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZERGKZ1987-11-25 View
510(k) K871600 SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.GKZ1987-06-24 View
510(k) K855116 SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEMGKZ1986-02-24 View
510(k) K855117 SYSMEX E-2500 AUTOMATED HEMATOLOGY SYSTEMGKZ1986-02-24 View
510(k) K850354 SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYSGKZ1985-05-20 View
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