|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
tetracxp system (software and system guide)
|
BECKMAN COULTER, INC.
|
K030828 |
05/21/2003
|
coulter a t 5diff cap pierce (cp)
|
BECKMAN COULTER, INC.
|
K042173 |
10/12/2004
|
counter, differential cell: Stem-Kit Reagents
|
Beckman Coulter, Inc.
|
BK040032 |
05/05/2004
|
counter, differential cell: stemCXP System for the FC 500 with CXP Software
|
Beckman Coulter, Inc.
|
BK040055 |
09/16/2004
|
flowcare plg cd4 reagent
|
BECKMAN COULTER, INC.
|
K043215 |
01/19/2005
|
modification to coulter lh 500 hematology analyzer
|
BECKMAN COULTER, INC.
|
K042724 |
10/29/2004
|
coulter lh 750 hematology analyzer
|
BECKMAN COULTER, INC.
|
K050057 |
02/10/2005
|
itag mhc tetramer cmv assay
|
BECKMAN COULTER, INC.
|
K051122 |
08/01/2005
|
modification to coulter lh 750 hematology analyzer
|
BECKMAN COULTER, INC.
|
K052905 |
11/18/2005
|
coulter lh 750 hematology analyzer, model 6605632
|
BECKMAN COULTER, INC.
|
K061574 |
07/21/2006
|
|