510(k) K973448 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469
| Applicant | Beckman Instruments, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Sep 17, 1998 |
| Received | Sep 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973448
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.