Source document or public record
FDA 510(k) K230161 — ONLINE TDM Phenytoin - Free Phenytoin application
FDA 510(k) index record K230161. Device: ONLINE TDM Phenytoin - Free Phenytoin application. Applicant as listed: Roche Diagnostics. Decision date: 2023-03-30.
Source
"device_name": "ONLINE TDM Phenytoin - Free Phenytoin application"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K230161.
Device name: ONLINE TDM Phenytoin - Free Phenytoin application. Applicant as listed: Roche Diagnostics.
Decision date: 2023-03-30. Decision wording: Substantially Equivalent.
Product code: MOJ. Regulation: 21 CFR 862.3350. 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.
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