510(k) K080869 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, May 23, 2008 |
| Received | Mar 31, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080869
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.