REAGENT FOR DETERM. POTASSIUM/IN HUMAN
Device Facts
| Record ID | K800692 |
|---|---|
| Device Name | REAGENT FOR DETERM. POTASSIUM/IN HUMAN |
| Applicant | Diagnostic Solutions, Inc. |
| Product Code | CEM · Clinical Chemistry |
| Decision Date | May 28, 1980 |
| 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.
