510(k) K083579 ยท JIX Calibrator, Multi-Analyte Mixture
DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Feb 20, 2009 |
| Received | Dec 4, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K083579
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.