510(k) K122397 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
| Applicant | DiaSorin, Inc., Stillwater MN, US |
| Decision | Substantially Equivalent, Sep 6, 2012 |
| Received | Aug 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122397
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.