K252523 is an FDA 510(k) clearance for the Healgen® Accurate Oral Fluid Drug Test COT/THC. This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K252523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | NFW — Test, Cannabinoid, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |