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FDA 510(k)

Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test

K-Number: K252523 · 2026-02-12

ApplicantHealgen Scientific,, LLC
Decision Date2026-02-12
Product CodeNFW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test 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 2026-02-12 under 510(k) number K252523. The device is classified under product code NFW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test?

Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test is a medical device that received FDA 510(k) clearance on 2026-02-12. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K252523.

When did Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test receive FDA 510(k) clearance?

Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test received FDA 510(k) clearance on 2026-02-12, under 510(k) number K252523.

Who is the listed applicant for Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test?

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® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test?

The FDA product code for Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test is NFW.

Other records listing Healgen Scientific,, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: NFW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231978BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50Vivachek Biotech (Hangzhou) Co., Ltd.K192301BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test StripShenzhen Bioeasy Biotechnology Co., Ltd.K191924SAFECARE® THC Urine Strip TestSafecare Biotech (Hangzhou) Co., Ltd.

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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