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FDA 510(k)

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

K-Number: K241969 · 2024-08-14

ApplicantQingdao Hightop Biotech Co., Ltd.
Decision Date2024-08-14
Product CodeNGL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Hightop Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-08-14 under 510(k) number K241969. 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 Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel?

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel is a medical device that received FDA 510(k) clearance on 2024-08-14. The listed applicant is Qingdao Hightop Biotech Co., Ltd.. The 510(k) number is K241969.

When did Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel receive FDA 510(k) clearance?

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel received FDA 510(k) clearance on 2024-08-14, under 510(k) number K241969.

Who is the listed applicant for Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel?

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

What is the FDA product code for Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel?

The FDA product code for Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel is NGL.

Related Clinical Trials

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Other records listing Qingdao Hightop 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.

K220685HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup RxK192123HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream

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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