JRE
- Product code
- JRE
- Device name
- Refractometer For Clinical Use
- Device class
- Class 1
- 21 CFR
- 21 CFR 862.2800
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (all years, FDA)
- 13 (all years; only the last 3 years are listed here)
Official FDA classification page: JRE
Classification and pathway per current FDA publications. Data from openFDA (CC0).