510(k) K071474 ยท NTV Myeloperoxidase, Immunoassay, System, Test
DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Dec 10, 2008 |
| Received | May 29, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071474
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.