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FDA 510(k)

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card

K-Number: K240686 · 2024-04-12

ApplicantHealgen Scientific,, LLC
Decision Date2024-04-12
Product CodeNGL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card is the device name listed in this FDA 510(k) record. The listed applicant is Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2024-04-12 under 510(k) number K240686. 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 Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card?

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K240686.

When did Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card receive FDA 510(k) clearance?

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card received FDA 510(k) clearance on 2024-04-12, under 510(k) number K240686.

Who is the listed applicant for Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card?

The FDA 510(k) record lists Healgen Scientific,, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card?

The FDA product code for Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card is NGL.

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Other records listing Healgen Scientific,, LLC as applicant

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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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