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FDA 510(k)

AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup

K-Number: K252259 · 2025-08-15

ApplicantAssure Tech., LLC
Decision Date2025-08-15
Product CodeNFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup is a medical device manufactured by Assure Tech., LLC. It received FDA 510(k) clearance on 2025-08-15 under approval number K252259. 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 AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup?

AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2025-08-15. It is manufactured by Assure Tech., LLC. The 510(k) number is K252259.

When was AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup approved by the FDA?

AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup received FDA 510(k) clearance on 2025-08-15, under approval number K252259.

What company makes AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup?

AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup is manufactured by Assure Tech., LLC.

What is the FDA product code for AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup?

The FDA product code for AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup is NFT.

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Other Devices by Assure Tech., LLC

K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream

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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