510(k) K010668 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY
| Applicant | Bayer Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Jul 5, 2001 |
| Received | Mar 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010668
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.