510(k) K981282 ยท LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
ELECSYS AFP
| Applicant | Roche Diagnostics GmbH, Pleasanton CA, US |
| Decision | Substantially Equivalent, May 1, 1998 |
| Received | Apr 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981282
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.