510(k) K993291 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
COPALIS RUBELLA IGM
| Applicant | DiaSorin, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Feb 10, 2000 |
| Received | Oct 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993291
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.