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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

ApplicantHealgen Scientific,, LLC
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 a medical device manufactured by Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2024-12-17 under approval 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. It is manufactured by Healgen Scientific,, LLC. The 510(k) number is K243365.

When was Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup approved by the FDA?

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 approval number K243365.

What company makes 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 manufactured by Healgen Scientific,, LLC.

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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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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