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FDA 510(k)

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT

K-Number: K223162 · 2023-03-17

ApplicantHealgen Scientific,, LLC
Decision Date2023-03-17
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT is a medical device manufactured by Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2023-03-17 under approval number K223162. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT?

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT is a medical device that received FDA 510(k) clearance on 2023-03-17. It is manufactured by Healgen Scientific,, LLC. The 510(k) number is K223162.

When was Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT approved by the FDA?

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT received FDA 510(k) clearance on 2023-03-17, under approval number K223162.

What company makes Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT?

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT is manufactured by Healgen Scientific,, LLC.

What is the FDA product code for Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT?

The FDA product code for Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT is LDJ.

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Related Devices (Code: LDJ)

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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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