510(k) K853069 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 1, 1986 |
| Received | Jul 22, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853069
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.