Documento fuente o registro público

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.

OtherU.S. Food and Drug Administration (FDA)2025-04-15

Fuente

"device_name": "Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup"

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-25

Disclaimer

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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