510(k) K002453 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Aug 31, 2000 |
| Received | Aug 10, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002453
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.