510(k) K001468 ยท MOI System, Test, Immunological, Antigen, Tumor
ELECSYS CA 15-3 TEST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 23, 2000 |
| Received | May 10, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001468
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.