510(k) K090236 ยท LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Apr 27, 2009 |
| Received | Feb 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090236
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.