EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)
Device Facts
| Record ID | K961115 |
|---|---|
| Device Name | EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) |
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc. |
| Product Code | CEM · Clinical Chemistry |
| Decision Date | May 7, 1996 |
| 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.
