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FDA 510(k)

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

K-Number: K181790 · 2018-07-26

ApplicantHangzhou Clongene Biotech Co., Ltd.
Decision Date2018-07-26
Product CodeNGL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup is a medical device manufactured by Hangzhou Clongene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2018-07-26 under approval number K181790. 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 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup?

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup is a medical device that received FDA 510(k) clearance on 2018-07-26. It is manufactured by Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K181790.

When was CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup approved by the FDA?

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup received FDA 510(k) clearance on 2018-07-26, under approval number K181790.

What company makes CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup?

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup is manufactured by Hangzhou Clongene Biotech Co., Ltd..

What is the FDA product code for CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup?

The FDA product code for CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup is NGL.

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Related Devices (Code: NGL)

K190412CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd. K193480BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology 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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