Source document or public record
FDA 510(k) K242767 — Safecare Urinary Tract Infection Test
FDA 510(k) index record K242767. Device: Safecare Urinary Tract Infection Test. Applicant as listed: Safecare Biotech (Hangzhou) Co., Ltd.. Decision date: 2025-01-10.
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"device_name": "Safecare Urinary Tract Infection Test"
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
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FDA 510(k) public index record K242767.
Device name: Safecare Urinary Tract Infection Test. Applicant as listed: Safecare Biotech (Hangzhou) Co., Ltd..
Decision date: 2025-01-10. 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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