510(k) K885300 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
CAPTIA(R) RUBELLA-M
| Applicant | Mercia Diagnostics , Ltd., Guildford, Surrey England, GB |
| Decision | Substantially Equivalent, Aug 15, 1989 |
| Received | Dec 27, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885300
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.