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Device Name
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Applicant
|
510(K) Number
|
Decision Date
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access accutni reagent, access accutni calibrator, unicel dxi 800 access immunoassay system
|
BECKMAN COULTER, INC.
|
K121790 |
09/25/2013
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access accutni+3 reagent and access accutn1+3 calibrators for use on the access 2 immunoassay system
|
BECKMAN COULTER, INC.
|
K121214 |
06/14/2013
|
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
|
au5800(r) chemistry analyzer
|
BECKMAN COULTER, INC.
|
K112412 |
12/23/2011
|
power processor sample processing system with generic connection module, model: 4210
|
BECKMAN COULTER, INC.
|
K090588 |
05/27/2009
|
power processor sample processing system with generic connections
|
BECKMAN COULTER, INC.
|
K110413 |
05/11/2011
|
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 dxc 600 and 800 synchron systems
|
BECKMAN COULTER, INC.
|
K042291 |
11/12/2004
|
|