Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Accurate Multi Panel Drug Urine Test Cup

K-Number: K191841 · 2019-08-07

ApplicantHealstone Biotech, Inc.
Decision Date2019-08-07
Product CodeNFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Accurate Multi Panel Drug Urine Test Cup is a medical device manufactured by Healstone Biotech, Inc.. It received FDA 510(k) clearance on 2019-08-07 under approval number K191841. 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 Accurate Multi Panel Drug Urine Test Cup?

Accurate Multi Panel Drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2019-08-07. It is manufactured by Healstone Biotech, Inc.. The 510(k) number is K191841.

When was Accurate Multi Panel Drug Urine Test Cup approved by the FDA?

Accurate Multi Panel Drug Urine Test Cup received FDA 510(k) clearance on 2019-08-07, under approval number K191841.

What company makes Accurate Multi Panel Drug Urine Test Cup?

Accurate Multi Panel Drug Urine Test Cup is manufactured by Healstone Biotech, Inc..

What is the FDA product code for Accurate Multi Panel Drug Urine Test Cup?

The FDA product code for Accurate Multi Panel Drug Urine Test Cup is NFT.

Related Clinical Trials

NCT06616506 Artificial Intelligence for Highly Myopic Cataract RECRUITING NCT07571226 Identification and Molecular Characterisation of Urban-environmental Stress Patterns Affecting Mental Illness NOT_YET_RECRUITING NCT05070572 Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output COMPLETED NCT06862440 Kegg Fertility Study ACTIVE_NOT_RECRUITING NCT07288593 INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention NOT_YET_RECRUITING NCT06645613 TMS With Real-time E-field and EEG Source Imaging ACTIVE_NOT_RECRUITING

Related PubMed Literature

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 Healstone Biotech, Inc.

K221871Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx K212418hCG One Step Pregnancy Test

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.

↑