|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
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synchron cx pro clinical systems, model cx4 pro, cx5 pro, cx7 pro, cx9 pro
|
BECKMAN COULTER, INC.
|
K011465 |
06/08/2001
|
synchron lx i 725 clinical system
|
BECKMAN COULTER, INC.
|
K023049 |
10/04/2002
|
unicel dxi 800 access immunoassay system, model 973100
|
BECKMAN COULTER, INC.
|
K023764 |
01/28/2003
|
unicel dxc 600 and 800 synchron systems
|
BECKMAN COULTER, INC.
|
K042291 |
11/12/2004
|
unicel dxc 600i synchron access clinical system
|
BECKMAN COULTER, INC.
|
K060256 |
02/27/2006
|
power processor sample processing system with generic connection module, model: 4210
|
BECKMAN COULTER, INC.
|
K090588 |
05/27/2009
|
unicel dxc 600 synchron system software version 5.0 and unicel dxc 800 synchron system software version 5.0
|
BECKMAN COULTER, INC.
|
K103842 |
04/27/2011
|
au5800(r) chemistry analyzer
|
BECKMAN COULTER, INC.
|
K112412 |
12/23/2011
|
power processor sample processing system with generic connections
|
BECKMAN COULTER, INC.
|
K110413 |
05/11/2011
|
access accutni reagent, access accutni calibrator, unicel dxi 800 access immunoassay system
|
BECKMAN COULTER, INC.
|
K121790 |
09/25/2013
|
|