Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
269
Total
269
Cleared
0
Denied
45 devices
Cleared
Feb 10, 2005
COULTER LH 750 HEMATOLOGY ANALYZER
Hematology
30d
Cleared
Jan 19, 2005
FLOWCARE PLG CD4 REAGENT
Hematology
61d
Cleared
Oct 29, 2004
MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER
Hematology
28d
Cleared
Oct 12, 2004
COULTER A T 5DIFF CAP PIERCE (CP)
Hematology
62d
Cleared
Sep 26, 2003
COULTER LH 750 HEMATOLOGY ANALYZER
Hematology
59d
Cleared
Aug 13, 2003
COULTER LH 500 HEMATOLOGY ANALYZER
Hematology
64d
Cleared
Jul 24, 2003
COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
Hematology
24d
Cleared
May 21, 2003
TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)
Hematology
68d
Cleared
Apr 21, 2003
COULTER LH 750 BODY FLUIDS APPLICATION
Hematology
55d
Cleared
Apr 17, 2003
COULTER ACT 5DIFF AUTOLOADER (AL)
Hematology
79d
Cleared
Mar 04, 2003
CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT,...
Hematology
25d
Cleared
Jul 29, 2002
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
Hematology
26d
Cleared
Jun 11, 2002
COULTER CELLPREP
Hematology
62d
Cleared
Dec 13, 2001
IMMUNO-TROL LOW CELLS
Hematology
23d
Cleared
Jul 10, 2001
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
Hematology
119d
Cleared
Jul 09, 2001
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
Hematology
68d
Cleared
Apr 13, 2001
COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
Hematology
30d
Cleared
Feb 07, 2001
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
Hematology
30d
Cleared
Feb 07, 2001
5C-ES CELL CONTROL, MODELS 7547191, 7547192
Hematology
30d
Cleared
Jul 06, 1998
VIGIL HEMOGLOBIN (HBALC) CONTROLS
Hematology
27d