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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 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 2023-07-31 under 510(k) 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. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K231698.

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

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

Who is the listed applicant for AllTest Fentanyl Rapid Test (Urine)?

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 Rapid Test (Urine)?

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

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: DJG)

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.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, 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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