510(k) K012075 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Jan 10, 2002 |
| Received | Jul 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012075
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.