K253705 is an FDA 510(k) clearance for the Healgen® Accurate Oral Fluid Drug Test. This device is classified as a Thin Layer Chromatography, Methamphetamine (Class II - Special Controls, product code DJC).
Submitted by Healgen Scientific, LLC (Houston, US). The FDA issued a Cleared decision on March 16, 2026, 112 days after receiving the submission on November 24, 2025.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3610.
| 510(k) Number | K253705 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2025 |
| Decision Date | March 16, 2026 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DJC — Thin Layer Chromatography, Methamphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3610 |