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FDA 510(k)

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

K-Number: K243996 · 2025-02-07

ApplicantAssure Tech., LLC
Decision Date2025-02-07
Product CodeNFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup is a medical device manufactured by Assure Tech., LLC. It received FDA 510(k) clearance on 2025-02-07 under approval number K243996. 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 Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup?

AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2025-02-07. It is manufactured by Assure Tech., LLC. The 510(k) number is K243996.

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

AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup received FDA 510(k) clearance on 2025-02-07, under approval number K243996.

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

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

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

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

Related Clinical Trials

NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT03952598 Studying the Biology of IDH-mutant Gliomas Via Longitudinal Observation of 2-hydroxyglutarate (2-HG) Using MR Spectroscopy SUSPENDED NCT05072483 Natural History Study of CADASIL RECRUITING NCT02543983 Neurobiology of Suicide RECRUITING NCT05236010 Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury RECRUITING NCT02911103 Deep Brain Stimulation Surgery for Focal Hand Dystonia ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41153261 From Lab to Clinic: Artificial Intelligence with Spectroscopic Liquid Biopsies. Diagnostics (Basel, Switzerland) (2025) PMID: 40886259 BRCA-CN: a blockchain-based framework to support public variant databases sharing in multi-center community for diagnostic reference and China regulatory science. Human genetics (2025)

Other Devices by Assure Tech., LLC

K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette 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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