JGS
- Product code
- JGS
- Device name
- Electrode, Ion Specific, Sodium
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1665
- Medical specialty
- Clinical Chemistry
- 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)
- 162 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252475 | 2026-05-01 | Radiometer Medicals Aps | ABL90 FLEX PLUS System | |
| K230275 | 2023-10-27 | Abbott Point of Care, Inc. | i-STAT CG8+ cartridge with the i-STAT 1 System |
Official FDA classification page: JGS
Classification and pathway per current FDA publications. Data from openFDA (CC0).