510(k) K031606 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jun 20, 2003 |
| Received | May 22, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031606
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.