FDA product code CEM
Electrode, Ion Specific, Potassium
Clinical Chemistry·Class 2·21 CFR 862.1600
US regulatory classifications
- US Product Code (FDA)
- CEMView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 862.1600View CFR Regulation →
- Medical specialty
- Clinical Chemistry
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
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About this record
Electrode, Ion Specific, Potassium is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.