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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 the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-10-26 under 510(k) 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. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K233417.

When did AllTest Fentanyl Urine Test Cassette receive FDA 510(k) clearance?

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

Who is the listed applicant for AllTest Fentanyl Urine Test Cassette?

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

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 records listing Hangzhou AllTest 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.

K260342AllTest Strep A Rapid TestK252607AllTest Urinary Tract Infection TestK251053Shinetell PlusTM Digital Early Pregnancy TestK250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupK242576AllTest Viral Transport MediumK244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test 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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