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FDA 510(k)

AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx

K-Number: K233019 · 2023-12-13

ApplicantHangzhou AllTest Biotech Co., Ltd.
Decision Date2023-12-13
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx is a medical device manufactured by Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-12-13 under approval number K233019. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx?

AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K233019.

When was AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx approved by the FDA?

AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx received FDA 510(k) clearance on 2023-12-13, under approval number K233019.

What company makes AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx?

AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx is manufactured by Hangzhou AllTest Biotech Co., Ltd..

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

The FDA product code for AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx is DKZ.

Related Clinical Trials

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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) PMID: 40794850 Regulatory Approved Point-of-Care Diagnostics (FDA & Health Canada): A Comprehensive Framework for Analytical Validity, Clinical Validity, and Clinical Utility in Medical Devices. The journal of applied laboratory medicine (2025)

Other Devices by Hangzhou AllTest Biotech Co., Ltd.

K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) K203272Alltest Pregnancy Rapid Combo Test Cassette K233417AllTest Fentanyl Urine Test Cassette K231698AllTest Fentanyl Rapid Test (Urine) K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel K241978Shinetell Digital Pregnancy Test

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Related Devices (Code: DKZ)

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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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