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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 the device name listed in this FDA 510(k) record. The listed applicant is Healstone Biotech, Inc.. It received FDA 510(k) clearance on 2019-08-07 under 510(k) 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. The listed applicant is Healstone Biotech, Inc.. The 510(k) number is K191841.

When did Accurate Multi Panel Drug Urine Test Cup receive FDA 510(k) clearance?

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

Who is the listed applicant for Accurate Multi Panel Drug Urine Test Cup?

The FDA 510(k) record lists Healstone Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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Other records listing Healstone Biotech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221871Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup RxK212418hCG One Step Pregnancy Test

Related Devices (Code: NFT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261984AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupAssure Tech., LLCK261280BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelVivachek Biotech (Hangzhou) Co., Ltd.K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxGuangzhou Wondfo Biotech Co., Ltd.K260355Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CupWEBEST Biotech,, LLCK252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxGuangzhou Wondfo Biotech Co., Ltd.K252867VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupAdvin Biotech, Inc.

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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