STAT K SYSTEM
Device Facts
| Record ID | K915345 |
|---|---|
| Device Name | STAT K SYSTEM |
| Applicant | Portable Diagnostic Services, Inc. |
| Product Code | CEM · Clinical Chemistry |
| Decision Date | Jul 16, 1992 |
| 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.
