510(k) K821743 ยท LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY
| Applicant | Syva Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 2, 1982 |
| Received | Jun 14, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821743
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2026 | Siemens Healthcare Diagnostics, Inc. Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls
SMN 10445390
Catalog No. 7C219UL Open, Classified |
LFG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.