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FDA 510(k)

AllTest Fentanyl Rapid Test (Urine)

K-Number: K231698 · 2023-07-31

ApplicantHangzhou AllTest Biotech Co., Ltd.
Decision Date2023-07-31
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AllTest Fentanyl Rapid Test (Urine) is a medical device manufactured by Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-07-31 under approval number K231698. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AllTest Fentanyl Rapid Test (Urine)?

AllTest Fentanyl Rapid Test (Urine) is a medical device that received FDA 510(k) clearance on 2023-07-31. It is manufactured by Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K231698.

When was AllTest Fentanyl Rapid Test (Urine) approved by the FDA?

AllTest Fentanyl Rapid Test (Urine) received FDA 510(k) clearance on 2023-07-31, under approval number K231698.

What company makes AllTest Fentanyl Rapid Test (Urine)?

AllTest Fentanyl Rapid Test (Urine) is manufactured by Hangzhou AllTest Biotech Co., Ltd..

What is the FDA product code for AllTest Fentanyl Rapid Test (Urine)?

The FDA product code for AllTest Fentanyl Rapid Test (Urine) is DJG.

Related Clinical Trials

NCT05333679 Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study) COMPLETED NCT03065335 Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder RECRUITING

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 K233417AllTest Fentanyl Urine Test Cassette K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel K241978Shinetell Digital Pregnancy Test

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Related Devices (Code: DJG)

K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 TestsChemtron Biotech, Inc. K173183CEDIA Heroin Metabolite (6-AM) AssayMicrogenics Corporation K172910Emit II Plus Oxycodone AssaySiemens Healthcare Diagnostics, Inc. K161216Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine CalibratorsImmunalysis Corporation K163101CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control SetMicrogenics Corporation

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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