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FDA 510(k)

BIOEASY Multi-Drug Test Cup

K-Number: K193480 · 2020-01-31

ApplicantShenzhen Bioeasy Biotechnology Co., Ltd.
Decision Date2020-01-31
Product CodeNGL
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 2020-01-31 under 510(k) number K193480. The device is classified under product code NGL. 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 2020-01-31. The listed applicant is Shenzhen Bioeasy Biotechnology Co., Ltd.. The 510(k) number is K193480.

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

BIOEASY Multi-Drug Test Cup received FDA 510(k) clearance on 2020-01-31, under 510(k) number K193480.

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 NGL.

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 RxK192515BIOEASY 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 StripK182530BIOEASY Multi-Drug Test Cup

Related Devices (Code: NGL)

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.

K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardHealgen Scientific,, LLCK250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupAnhui Deepblue Medical Technological Co., Ltd.K250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProGuangzhou Decheng Biotechnology Co., Ltd.K242428Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup PlusGuangzhou Decheng Biotechnology Co., Ltd.K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test CupHealgen Scientific,, LLCK243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home TestEterbio, 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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