510(k) K012357 ยท MOI System, Test, Immunological, Antigen, Tumor
CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM
| Applicant | Bayer Diagnostics Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Feb 28, 2002 |
| Received | Jul 25, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012357
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.