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FDA 510(k)

CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette

K-Number: K242802 · 2024-11-08

ApplicantHangzhou Clongene Biotech Co., Ltd.
Decision Date2024-11-08
Product CodeNGL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette is a medical device manufactured by Hangzhou Clongene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-11-08 under approval number K242802. 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 Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette?

CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette is a medical device that received FDA 510(k) clearance on 2024-11-08. It is manufactured by Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K242802.

When was CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette approved by the FDA?

CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette received FDA 510(k) clearance on 2024-11-08, under approval number K242802.

What company makes CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette?

CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette is manufactured by Hangzhou Clongene Biotech Co., Ltd..

What is the FDA product code for CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette?

The FDA product code for CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette is NGL.

Other Devices by Hangzhou Clongene Biotech Co., Ltd.

K161251CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests K153741CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test K181790CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup K180255CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup K193132CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream K190412CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

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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. 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.

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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