510(k) K112142 ยท NDW Assay, Porphyrin, Spectrophotometry, Lithium
DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Nov 4, 2011 |
| Received | Jul 26, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112142
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2013 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product. Terminated |
KXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.