Source document or public record
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.
Source
"device_name": "iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip"
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 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.
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