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FDA 510(k)

Healgen® Accurate Oral Fluid Drug Test

K-Number: K253705 · 2026-03-16

ApplicantHealgen Scientific,, LLC
Decision Date2026-03-16
Product CodeDJC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Healgen® Accurate Oral Fluid Drug Test is a medical device manufactured by Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2026-03-16 under approval number K253705. The device is classified under product code DJC. 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 is a medical device that received FDA 510(k) clearance on 2026-03-16. It is manufactured by Healgen Scientific,, LLC. The 510(k) number is K253705.

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

Healgen® Accurate Oral Fluid Drug Test received FDA 510(k) clearance on 2026-03-16, under approval number K253705.

What company makes Healgen® Accurate Oral Fluid Drug Test?

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

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

The FDA product code for Healgen® Accurate Oral Fluid Drug Test is DJC.

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Other Devices by Healgen Scientific,, LLC

K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card K163704Healgen 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

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Related Devices (Code: DJC)

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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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