DKZ
- Product code
- DKZ
- Device name
- Enzyme Immunoassay, Amphetamine
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.3100
- 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)
- 225 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240670 | 2024-10-30 | Microgenics Corporation | DRI Ecstasy Plus Assay | |
| K233019 | 2023-12-13 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Dru… |
Official FDA classification page: DKZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).