510(k) K062236 ยท MKW Cyclosporine
DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Aug 21, 2006 |
| Received | Aug 2, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062236
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.