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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 the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-11-08 under 510(k) 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. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K242802.

When did CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette receive FDA 510(k) clearance?

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

Who is the listed applicant for CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette?

The FDA 510(k) record lists Hangzhou Clongene Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Hangzhou Clongene Biotech 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.

K253318Clungene RSV Antigen Rapid TestK252118CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy CupK193132CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test MidstreamK190412CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupK181790CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupK180255CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

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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

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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