NDW
- Product code
- NDW
- Device name
- Assay, Porphyrin, Spectrophotometry, Lithium
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.3560
- Medical specialty
- Clinical Toxicology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 7 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243462 | 2025-08-01 | Diazyme Laboratories, Inc. | Diazyme Colorimetric Lithium Assay | — |
Official FDA classification page: NDW
Classification and pathway per current FDA publications. Data from openFDA (CC0).