FDA 510(k) Applications Submitted by STAN SUGRUE

FDA 510(k) Number Submission Date Device Name Applicant
K010064 01/08/2001 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 BECKMAN COULTER, INC.
K010066 01/08/2001 5C-ES CELL CONTROL, MODELS 7547191, 7547192 BECKMAN COULTER, INC.
K050057 01/11/2005 COULTER LH 750 HEMATOLOGY ANALYZER BECKMAN COULTER, INC.
K030408 02/07/2003 CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A BECKMAN COULTER, INC.
K030606 02/25/2003 COULTER LH 750 BODY FLUIDS APPLICATION BECKMAN COULTER, INC.
K010765 03/14/2001 COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 BECKMAN COULTER, INC.
K030828 03/14/2003 TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) BECKMAN COULTER, INC.
K011342 05/02/2001 COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 BECKMAN COULTER, INC.
K032000 06/10/2003 COULTER LH 500 HEMATOLOGY ANALYZER BECKMAN COULTER, INC.
K022161 07/03/2002 MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 BECKMAN COULTER, INC.
K032342 07/29/2003 COULTER LH 750 HEMATOLOGY ANALYZER BECKMAN COULTER, INC.
K042724 10/01/2004 MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER BECKMAN COULTER, INC.
K993356 10/06/1999 COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES COULTER CORP.
K052905 10/14/2005 MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER BECKMAN COULTER, INC.
K043215 11/19/2004 FLOWCARE PLG CD4 REAGENT BECKMAN COULTER, INC.


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