DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
Device Facts
| Record ID | K010061 |
|---|---|
| Device Name | DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND |
| Applicant | Dade Behring, Inc. |
| Product Code | CEM · Clinical Chemistry |
| Decision Date | Mar 14, 2001 |
| 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.
