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Coulter Immunology

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K922745CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1February 5, 1993
K922744CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1February 5, 1993
K910473CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITCOctober 31, 1991
K911793COULTERCLONEJuly 9, 1991
K893853COULTER CLONE T8 MONOCLONAL ANTIBODYMarch 2, 1990
K893852COULTER CLONE T4 MONOCLONAL ANTIBODYMarch 2, 1990
K894179COULTER CLONE(R) MY4 MONOCLONAL ANTIBODYFebruary 12, 1990
K895917CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTIDecember 29, 1989
K884605COULTER CLONE MO2August 15, 1989
K893419COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)August 3, 1989
K884020COULTER CLONE B4 MONOCLONAL ANTIBODYFebruary 3, 1989
K883753COULTER CLONE T1 MONOCLONAL ANTIBODYFebruary 3, 1989
K883710COULTER CLONE T3 MONOCLONAL ANTIBODYFebruary 3, 1989
K884346CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTIDecember 27, 1988
K883836COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-IINovember 30, 1988
K882557COULTER CLONE B1 MONOCLONAL ANTIBODYSeptember 14, 1988