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FDA 510(k)

AllTest Fentanyl Urine Test Cassette

K-Number: K233417 · 2023-10-26

ApplicantHangzhou AllTest Biotech Co., Ltd.
Decision Date2023-10-26
Product CodeNGL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AllTest Fentanyl Urine Test Cassette is a medical device manufactured by Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-10-26 under approval number K233417. 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 AllTest Fentanyl Urine Test Cassette?

AllTest Fentanyl Urine Test Cassette is a medical device that received FDA 510(k) clearance on 2023-10-26. It is manufactured by Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K233417.

When was AllTest Fentanyl Urine Test Cassette approved by the FDA?

AllTest Fentanyl Urine Test Cassette received FDA 510(k) clearance on 2023-10-26, under approval number K233417.

What company makes AllTest Fentanyl Urine Test Cassette?

AllTest Fentanyl Urine Test Cassette is manufactured by Hangzhou AllTest Biotech Co., Ltd..

What is the FDA product code for AllTest Fentanyl Urine Test Cassette?

The FDA product code for AllTest Fentanyl Urine Test Cassette is NGL.

Other Devices by Hangzhou AllTest Biotech Co., Ltd.

K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) K203272Alltest Pregnancy Rapid Combo Test Cassette K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx K231698AllTest Fentanyl Rapid Test (Urine) K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel K241978Shinetell Digital Pregnancy Test

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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. 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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