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FDA 510(k)

AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel

K-Number: K242540 · 2024-09-27

ApplicantHangzhou AllTest Biotech Co., Ltd.
Decision Date2024-09-27
Product CodeNFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K242540. 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 AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel?

AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K242540.

When did AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel receive FDA 510(k) clearance?

AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel received FDA 510(k) clearance on 2024-09-27, under 510(k) number K242540.

Who is the listed applicant for AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel?

The FDA 510(k) record lists Hangzhou AllTest Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel?

The FDA product code for AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel is NFT.

Related Clinical Trials

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.

NCT03065335Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive DisorderRECRUITINGNCT05333679Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)COMPLETED

Other records listing Hangzhou AllTest Biotech Co., Ltd. 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.

K260342AllTest Strep A Rapid TestK252607AllTest Urinary Tract Infection TestK251053Shinetell PlusTM Digital Early Pregnancy TestK250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupK242576AllTest Viral Transport MediumK244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup

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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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