510(k) K894546 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
IMMUNODOT RUBELLA TEST
| Applicant | General Biometrics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 16, 1989 |
| Received | Jul 21, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894546
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.