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FDA 510(k)

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

K-Number: K153597 · 2016-05-23

ApplicantHealgen Scientific,, LLC
Decision Date2016-05-23
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine 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 2016-05-23 under 510(k) number K153597. 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 2016-05-23. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K153597.

When did Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card receive FDA 510(k) clearance?

Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card received FDA 510(k) clearance on 2016-05-23, under 510(k) number K153597.

Who is the listed applicant for Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine 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 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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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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