510(k) K063186 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Mar 21, 2007 |
| Received | Oct 20, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063186
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.