510(k) K031506 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jun 2, 2003 |
| Received | May 14, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031506
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.