510(k) K884247 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT
| Applicant | Disease Detection International, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 10, 1989 |
| Received | Oct 11, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884247
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.