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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