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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: 04/16/2024
 
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access tsh (3rd is) assay, dxi 9000 access immunoassay analyzer Beckman Coulter, Inc. K221225 11/10/2022
access vitamin b12 assay, access ferritin assay, access folate assay, access hypersensitive htsh assay, power express sample processing system generic connection module and access immunoassay system reagents BECKMAN COULTER, INC. K140496 09/16/2014
access accutni reagent, access accutni calibrator, unicel dxi 800 access immunoassay system BECKMAN COULTER, INC. K121790 09/25/2013
access accutni+3 reagent and access accutn1+3 calibrators for use on the access 2 immunoassay system BECKMAN COULTER, INC. K121214 06/14/2013
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
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 connection module, model: 4210 BECKMAN COULTER, INC. K090588 05/27/2009
unicel dxc 600i synchron access clinical system BECKMAN COULTER, INC. K060256 02/27/2006
unicel dxc 600 and 800 synchron systems BECKMAN COULTER, INC. K042291 11/12/2004
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