510(k) K090594 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Apr 29, 2009 |
| Received | Mar 5, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090594
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.