Documento fuente o registro público
FDA 510(k) K213875 — DRI TM Tricyclics Serum Tox Assay
FDA 510(k) index record K213875. Device: DRI TM Tricyclics Serum Tox Assay. Applicant as listed: Microgenics Corporation. Decision date: 2022-12-21.
Fuente
"device_name": "DRI TM Tricyclics Serum Tox Assay"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-30
professional use
FDA 510(k) public index record K213875.
Device name: DRI TM Tricyclics Serum Tox Assay. Applicant as listed: Microgenics Corporation.
Decision date: 2022-12-21. Decision wording: Substantially Equivalent.
Product code: LFH. Regulation: 21 CFR 862.3910. Medical specialty: Clinical Toxicology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.