LDJ
- Product code
- LDJ
- Device name
- Enzyme Immunoassay, Cannabinoids
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.3870
- 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)
- 150 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232732 | 2024-01-17 | Co-Innovation Biotech Co., Ltd. | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana… | |
| K232604 | 2024-01-10 | Hangzhou Laihe Biotech Co., Ltd. | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER… |
Official FDA classification page: LDJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).