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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 13 Results
ProductCode: JJE Applicant: BECKMAN COULTER, INC. Decision Date To: 04/19/2024
 
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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
power processor sample processing system with generic connections BECKMAN COULTER, INC. K110413 05/11/2011
au5800(r) chemistry analyzer BECKMAN COULTER, INC. K112412 12/23/2011
access accutni+3 reagent and access accutn1+3 calibrators for use on the access 2 immunoassay system BECKMAN COULTER, INC. K121214 06/14/2013
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