510(k) K010588 ยท MOI System, Test, Immunological, Antigen, Tumor
ELECSYSCA 15-3 II ASSAY
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 28, 2001 |
| Received | Feb 27, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010588
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.