510(k) K020807 ยท LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
| Applicant | Bayer Diagnostics Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Oct 1, 2002 |
| Received | Mar 12, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020807
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.