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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 a medical device manufactured by Shenzhen Bioeasy Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2020-01-31 under approval 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. It is manufactured by Shenzhen Bioeasy Biotechnology Co., Ltd.. The 510(k) number is K193480.

When was BIOEASY Multi-Drug Test Cup approved by the FDA?

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

What company makes BIOEASY Multi-Drug Test Cup?

BIOEASY Multi-Drug Test Cup is manufactured by Shenzhen Bioeasy Biotechnology Co., Ltd..

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 Devices by Shenzhen Bioeasy Biotechnology Co., Ltd.

K182530BIOEASY Multi-Drug Test Cup K192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 K192301BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip K230238BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx

Related Devices (Code: NGL)

K181790CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd. K190412CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd. K233417AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd. K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test CupHealgen Scientific,, LLC K243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home TestEterbio, Inc. K242802CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteHangzhou Clongene Biotech Co., Ltd.

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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