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FDA 510(k)

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup

K-Number: K250803 · 2025-04-15

ApplicantAnhui Deepblue Medical Technological Co., Ltd.
Decision Date2025-04-15
Product CodeNGL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Deepblue Medical Technological Co., Ltd.. It received FDA 510(k) clearance on 2025-04-15 under 510(k) number K250803. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup?

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2025-04-15. The listed applicant is Anhui Deepblue Medical Technological Co., Ltd.. The 510(k) number is K250803.

When did Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup receive FDA 510(k) clearance?

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup received FDA 510(k) clearance on 2025-04-15, under 510(k) number K250803.

Who is the listed applicant for Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup?

The FDA 510(k) record lists Anhui Deepblue Medical Technological Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup?

The FDA product code for Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup is NGL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03394066Mechanism of Non-invasive Magnetic StimulationRECRUITINGNCT06825689Unidos Contra el VPHRECRUITING

Related Devices (Code: NGL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardHealgen Scientific,, LLCK250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProGuangzhou Decheng Biotechnology Co., Ltd.K242428Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup PlusGuangzhou Decheng Biotechnology Co., Ltd.K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test CupHealgen Scientific,, LLCK243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home TestEterbio, Inc.K242802CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteHangzhou Clongene Biotech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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