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FDA 510(k)

AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup

K-Number: K250727 · 2025-04-04

ApplicantHangzhou AllTest Biotech Co., Ltd.
Decision Date2025-04-04
Product CodeNFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup is a medical device manufactured by Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-04-04 under approval number K250727. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup?

AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2025-04-04. It is manufactured by Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K250727.

When was AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup approved by the FDA?

AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup received FDA 510(k) clearance on 2025-04-04, under approval number K250727.

What company makes AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup?

AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup is manufactured by Hangzhou AllTest Biotech Co., Ltd..

What is the FDA product code for AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup?

The FDA product code for AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup is NFT.

Related Clinical Trials

NCT07571226 Identification and Molecular Characterisation of Urban-environmental Stress Patterns Affecting Mental Illness NOT_YET_RECRUITING NCT05333679 Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study) COMPLETED NCT07288593 INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention NOT_YET_RECRUITING NCT03065335 Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder RECRUITING NCT05078853 Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma COMPLETED NCT04624880 COMT Activity and Hypnotizability COMPLETED

Related PubMed Literature

PMID: 40794850 Regulatory Approved Point-of-Care Diagnostics (FDA & Health Canada): A Comprehensive Framework for Analytical Validity, Clinical Validity, and Clinical Utility in Medical Devices. The journal of applied laboratory medicine (2025)

Other Devices by Hangzhou AllTest Biotech Co., Ltd.

K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) K203272Alltest Pregnancy Rapid Combo Test Cassette K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx K233417AllTest Fentanyl Urine Test Cassette K231698AllTest Fentanyl Rapid Test (Urine) K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel

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Related Devices (Code: NFT)

K170049AssureTech Panel Dip Test, AssureTech Quick Cup TestAssure Tech. (Hangzhou) Co, Ltd. K182701Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd. K182530BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd. K181968SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardSafecare Biotech (Hangzhou) Co., Ltd. K181768AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. K180349AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) 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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