510(k) K092322 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
ELECSYS RUBELLA IGM IMMUNOASSAY
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 12, 2010 |
| Received | Aug 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092322
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.