510(k) K003412 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
ADVIA CENTAUR RUBELLA IGG ASSAY
| Applicant | Bayer Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Apr 13, 2001 |
| Received | Nov 2, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003412
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.