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Toa Medical Electronics USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
33
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K936023SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZERMay 2, 1994
K933886TOA MEDICAL ELECTRONICS CA-5000January 27, 1994
K931149CA-1000 AUTOMATED COAGULATION ANALYZERNovember 3, 1993
K920544SYSMEX HEMATOLOGY SYSTEM ACCESSORIESApril 29, 1992
K914744SYSMEX NE-1500, MODIFICATIONDecember 30, 1991
K912494SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZERSeptember 10, 1991
K911172SYSMEX F-610July 26, 1991
K910849SYSMEX F-810July 26, 1991
K911173SYSMEX F-310July 26, 1991
K910745HEMOGLOBIN REAGENTJuly 11, 1991
K894539SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZERSeptember 26, 1989
K883997SYSMEX NE-8000December 5, 1988
K882370SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZERAugust 25, 1988
K882767SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEMJuly 18, 1988
K882267SYSMEX QUICKLYSER-II (QLS-200A)July 12, 1988
K873734SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZERNovember 25, 1987
K871600SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.June 24, 1987
K855116SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEMFebruary 24, 1986
K855117SYSMEX E-2500 AUTOMATED HEMATOLOGY SYSTEMFebruary 24, 1986
K850354SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYSMay 20, 1985