510(k) K875368 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
THE DDI SERODOT RUBELLA IGG TEST KIT
| Applicant | Disease Detection International, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 23, 1988 |
| Received | Dec 31, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K875368
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.