Source document or public record
FDA 510(k) K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
FDA 510(k) index record K250117. Device: FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette. Applicant as listed: Assure Tech., LLC. Decision date: 2025-02-13.
Source
"device_name": "FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette"
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 K250117.
Device name: FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette. Applicant as listed: Assure Tech., LLC.
Decision date: 2025-02-13. 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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