DJC
- Product code
- DJC
- Device name
- Thin Layer Chromatography, Methamphetamine
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.3610
- Medical specialty
- Clinical Toxicology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 31 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253705 | 2026-03-16 | Healgen Scientific,, LLC | Healgen® Accurate Oral Fluid Drug Test | |
| K240287 | 2025-03-18 | Hangzhou Laihe Biotech Co., Ltd. | LYHER® Oral fluid Multi-Drug Test Kit (Cube) |
Official FDA classification page: DJC
Classification and pathway per current FDA publications. Data from openFDA (CC0).