510(k) K063143 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 26, 2006 |
| Received | Oct 16, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063143
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.