Panels › Clinical Chemistry › Product code MKW · Class 2
Cyclosporine
Regulation 862.1235
0510(k)s in 12 months (9 all time)
0recalls in 12 months (5 all time)
4recalls that name a 510(k)
Top companies in MKW
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Cyclosporine Terminated |
MKW | K071455 |
| May 21, 2014 | Siemens Healthcare Diagnostics, Inc. Dimension Vista CSA and CSAE
The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measur Terminated |
MKW | K062236 |
| Jan 23, 2014 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Cyclosporine Flex reagent cartridge
an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measuremen Terminated |
MKW | K062236 |
| Nov 4, 2011 | Abbott Laboratories ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood Distributed by Abbott Laborator Terminated |
MKW | K080751 |
| Apr 15, 2011 | Roche Diagnostics Operations, Inc. Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for and Distributed by: Roche Diagnostics Corporation, Indianapolis, IN.
For the quantitative determi Terminated |
MKW | None listed |
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