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Device Name
|
Applicant
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510(K) Number
|
Decision Date
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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
|
|