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FDA 510(k)

Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card

K-Number: K163704 · 2017-08-02

ApplicantHealgen Scientific,, LLC
Decision Date2017-08-02
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card is a medical device manufactured by Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2017-08-02 under approval number K163704. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card?

Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card is a medical device that received FDA 510(k) clearance on 2017-08-02. It is manufactured by Healgen Scientific,, LLC. The 510(k) number is K163704.

When was Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card approved by the FDA?

Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card received FDA 510(k) clearance on 2017-08-02, under approval number K163704.

What company makes Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card?

Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card is manufactured by Healgen Scientific,, LLC.

What is the FDA product code for Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card?

The FDA product code for Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card is JXM.

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Other Devices by Healgen Scientific,, LLC

K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card K212623Healgen Strep A Rapid Test Strip (Throat Swab) K231045Healgen URS Test Strips K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup K240949Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)

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Related Devices (Code: JXM)

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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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