FDA 510(k)

Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup

K-Number: K243365 · 2024-12-17

Decision Date2024-12-17

Product CodeNGL

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup 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 2024-12-17 under 510(k) number K243365. 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 Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup?

Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K243365.

When did Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup receive FDA 510(k) clearance?

Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup received FDA 510(k) clearance on 2024-12-17, under 510(k) number K243365.

Who is the listed applicant for Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup?

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 Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup?

The FDA product code for Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup is NGL.

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Related Devices (Code: NGL)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.