Submission Details
| 510(k) Number | K252523 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 11, 2025 |
| Decision Date | February 12, 2026 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
Healgen? Accurate Oral Fluid Drug Test COT/THC; Healgen? Accurate Oral Fluid Drug Test
Feb 2026
Decision
185d
Days
Class 2
Risk
About This 510(k) Submission
K252523 is an FDA 510(k) clearance for the Healgen? Accurate Oral Fluid Drug Test COT/THC; Healgen? Accurate Oral Fluid Drug Test, a Test, Cannabinoid, Over The Counter (Class II — Special Controls, product code NFW), submitted by Healgen Scientific, LLC (Houston, US). The FDA issued a Cleared decision on February 12, 2026, 185 days after receiving the submission on August 11, 2025. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.
Device Classification
| Product Code | NFW — Test, Cannabinoid, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3870 |
Manufacturer
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