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FDA 510(k)

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

K-Number: K253567 · 2025-12-23

ApplicantHealgen Scientific,, LLC
Decision Date2025-12-23
Product CodeNGL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card is a medical device manufactured by Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2025-12-23 under approval number K253567. 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 2025-12-23. It is manufactured by Healgen Scientific,, LLC. The 510(k) number is K253567.

When was Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card approved by the FDA?

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card received FDA 510(k) clearance on 2025-12-23, under approval number K253567.

What company makes 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 manufactured by Healgen Scientific,, LLC.

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 Devices by Healgen Scientific,, LLC

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Related Devices (Code: NGL)

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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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