Healgen® Accurate Oral Fluid Drug Test COT/THC— 510(k) K252523
Substantially EquivalentHealgen Scientific,, LLC
FDA 510(k) clearance K252523 for Healgen® Accurate Oral Fluid Drug Test COT/THC, Substantially Equivalent on 2026-02-12. Applicant: Healgen Scientific,, LLC. Device class: 2.
Summary
Healgen Scientific lists two names, Healgen® Accurate Oral Fluid Drug Test COT/THC and Healgen® Accurate Oral Fluid Drug Test, under product code NFW, over-the-counter cannabinoid test. The record doesn't say how the two differ.
Class II, 21 CFR 862.3870. Clinical Toxicology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Healgen Scientific filed from Houston, Texas. FDA found it substantially equivalent 185 calendar days after receipt (August 11, 2025 to February 12, 2026).
Clearance details
- Device name as filed
- Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test
- Applicant
- Healgen Scientific,, LLC
- Product code
- Product code NFW
- Device class
- Class 2
- Regulation
- 21 CFR 862.3870
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.