Source document or public record
FDA 510(k) K250803 — Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
FDA 510(k) index record K250803. Device: Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup. Applicant as listed: Anhui Deepblue Medical Technological Co., Ltd.. Decision date: 2025-04-15.
Source
"device_name": "Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup"
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 K250803.
Device name: Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup. Applicant as listed: Anhui Deepblue Medical Technological Co., Ltd..
Decision date: 2025-04-15. Decision wording: Substantially Equivalent.
Product code: NGL. Regulation: 21 CFR 862.3650. Medical specialty: Clinical Toxicology.
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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