JIS
- Product code
- JIS
- Device name
- Calibrator, Primary
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1150
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (all years, FDA)
- 130 (all years; only the last 3 years are listed here)
Official FDA classification page: JIS
Classification and pathway per current FDA publications. Data from openFDA (CC0).