Documento fuente o registro público
FDA 510(k) K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
FDA 510(k) index record K241394. Device: iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip. Applicant as listed: Andon Health Co, Ltd.. Decision date: 2024-12-20.
Fuente
"device_name": "iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip"
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
2026-10-20
professional use
FDA 510(k) public index record K241394.
Device name: iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip. Applicant as listed: Andon Health Co, Ltd..
Decision date: 2024-12-20. Decision wording: Substantially Equivalent.
Product code: LCX. Regulation: 21 CFR 862.1155. Medical specialty: Clinical Chemistry.
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.