ULTRA LYTE POTASSIUM REAGENT KIT
Device Facts
| Record ID | K843454 |
|---|---|
| Device Name | ULTRA LYTE POTASSIUM REAGENT KIT |
| Applicant | Ultra Quest Diagnostics, Inc. |
| Product Code | CEM · Clinical Chemistry |
| Decision Date | Nov 27, 1984 |
| 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.
