510(k) K073501 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 9, 2008 |
| Received | Dec 13, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073501
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.