Electrode, Ion Specific, Magnesium
The Ion-Specific Electrode Magnesium Test is a clinical chemistry device that measures magnesium ion concentration in biological fluids using a magnesium-selective electrode, providing a rapid method for assessing magnesium status used in the evaluation of hypomagnesemia, hypermagnesemia, and related metabolic conditions. It is classified as FDA Class 1 (lowest risk). The product code is CFA, regulated under 21 CFR 862.1495, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.
Research product code CFA in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- CFA
- Device Class
- FDA class 1
- Regulation Number
- 862.1495
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.