ILEX PROMPT CLINICAL CHEMISTRY ANALYER
Device Facts
| Record ID | K853068 |
|---|---|
| Device Name | ILEX PROMPT CLINICAL CHEMISTRY ANALYER |
| Applicant | Ilex Corp. |
| Product Code | CEM · Clinical Chemistry |
| Decision Date | Oct 31, 1985 |
| 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.
