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FDA 510(k)

BIOEASY Multi-Drug Test Cup

K-Number: K182530 · 2018-11-09

ApplicantShenzhen Bioeasy Biotechnology Co., Ltd.
Decision Date2018-11-09
Product CodeNFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIOEASY Multi-Drug Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Bioeasy Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2018-11-09 under 510(k) number K182530. 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 BIOEASY Multi-Drug Test Cup?

BIOEASY Multi-Drug Test Cup is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is Shenzhen Bioeasy Biotechnology Co., Ltd.. The 510(k) number is K182530.

When did BIOEASY Multi-Drug Test Cup receive FDA 510(k) clearance?

BIOEASY Multi-Drug Test Cup received FDA 510(k) clearance on 2018-11-09, under 510(k) number K182530.

Who is the listed applicant for BIOEASY Multi-Drug Test Cup?

The FDA 510(k) record lists Shenzhen Bioeasy Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOEASY Multi-Drug Test Cup?

The FDA product code for BIOEASY Multi-Drug Test Cup is NFT.

Other records listing Shenzhen Bioeasy Biotechnology 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.

K230238BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup RxK193480BIOEASY Multi-Drug Test CupK192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20K192301BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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