Documento fuente o registro público
FDA 510(k) K212418 — hCG One Step Pregnancy Test
FDA 510(k) index record K212418. Device: hCG One Step Pregnancy Test. Applicant as listed: Healstone Biotech, Inc.. Decision date: 2022-06-30.
Fuente
"device_name": "hCG One Step Pregnancy Test"
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Review and references
Automated FDA record verification
2026-10-20
2026-10-31
professional use
FDA 510(k) public index record K212418.
Device name: hCG One Step Pregnancy Test. Applicant as listed: Healstone Biotech, Inc..
Decision date: 2022-06-30. 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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