JXM
- Product code
- JXM
- Device name
- Enzyme Immunoassay, Benzodiazepine
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.3170
- Medical specialty
- Clinical Toxicology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 90
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243498 | 2024-12-11 | Microgenics Corporation | Alinity c Benzodiazepines Reagent Kit |
Official FDA classification page: JXM
Classification and pathway per current FDA publications. Data from openFDA (CC0).