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FDA 510(k)

SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx

K-Number: K252550 · 2025-11-18

ApplicantGuangzhou Wondfo Biotech Co., Ltd.
Decision Date2025-11-18
Product CodeNFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx is a medical device manufactured by Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-11-18 under approval number K252550. 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 SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx?

SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx is a medical device that received FDA 510(k) clearance on 2025-11-18. It is manufactured by Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K252550.

When was SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx approved by the FDA?

SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx received FDA 510(k) clearance on 2025-11-18, under approval number K252550.

What company makes SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx?

SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx is manufactured by Guangzhou Wondfo Biotech Co., Ltd..

What is the FDA product code for SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx?

The FDA product code for SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx is NFT.

Related Clinical Trials

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Other Devices by Guangzhou Wondfo Biotech Co., Ltd.

K161214Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) K162333Wondfo One Step Fecal Occult Blood (FOB) Test K182701Wondfo T-Cup Multi-Drug Urine Test Cup K173229Preview Digital Pregnancy Test K202567Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx K241317Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

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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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