Source document or public record
FDA 510(k) K251800 — Healgen® URS Test Strips
FDA 510(k) index record K251800. Device: Healgen® URS Test Strips. Applicant as listed: Healgen Scientific,, LLC. Decision date: 2025-12-23.
Source
"device_name": "Healgen® URS Test Strips"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K251800.
Device name: Healgen® URS Test Strips. Applicant as listed: Healgen Scientific,, LLC.
Decision date: 2025-12-23. Decision wording: Substantially Equivalent.
Product code: JMT. Regulation: 21 CFR 862.1510. 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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