510(k) K801204 ยท KLR Enzyme Immunoassay, Lidocaine
EMIT DISOPYRAMIDE ASSAY
| Applicant | Syva Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 9, 1980 |
| Received | May 19, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801204
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2026 | Siemens Healthcare Diagnostics, Inc. Syva Emit Disopyramide Assay
Enzyme Immunoassay, Lidocaine
SMN 10445370
Catalog No 6N319UL Open, Classified |
KLR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.