510(k) K093837 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM
| Applicant | Zeus Scientific, Inc. (Zeus), Raritan NJ, US |
| Decision | Substantially Equivalent, Oct 1, 2010 |
| Received | Dec 15, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093837
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.