CEM
- Product code
- CEM
- Device name
- Electrode, Ion Specific, Potassium
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1600
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 89 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253491 | 2026-02-12 | Roche Diagnostics | ISE indirect K for Gen.2; ISE indirect Na for Gen.2;… | |
| K241037 | 2025-01-14 | Radiometer Medicals Aps | ABL90 FLEX PLUS System | |
| K220396 | 2023-09-26 | Medica Corporation | EasyStat 300 |
Official FDA classification page: CEM
Classification and pathway per current FDA publications. Data from openFDA (CC0).