Source document or public record
FDA 510(k) K210341 — One Step Pregnancy Test
FDA 510(k) index record K210341. Device: One Step Pregnancy Test. Applicant as listed: Spd Swiss Precision Diagnostics GmbH. Decision date: 2022-03-10.
Source
"device_name": "One Step Pregnancy Test"
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 K210341.
Device name: One Step Pregnancy Test. Applicant as listed: Spd Swiss Precision Diagnostics GmbH.
Decision date: 2022-03-10. 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.