SERUM POTASSIUM REAGENT SET
Device Facts
| Record ID | K861713 |
|---|---|
| Device Name | SERUM POTASSIUM REAGENT SET |
| Applicant | Sterling Diagnostics, Inc. |
| Product Code | CEJ · Clinical Chemistry |
| Decision Date | May 23, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1600 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
