POTASSIUM SODIUM ANALYSIS PRODUCTS
Device Facts
| Record ID | K833535 |
|---|---|
| Device Name | POTASSIUM SODIUM ANALYSIS PRODUCTS |
| Applicant | Shaban Mfg. Co. |
| Product Code | JJO · Clinical Chemistry |
| Decision Date | Dec 29, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2540 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A flame emission photometer for clinical use is a device intended to measure the concentration of sodium, potassium, lithium, and other metal ions in body fluids. Abnormal variations in the concentration of these substances in the body are indicative of certain disorders (e.g., electrolyte imbalance and heavy metal intoxication) and are, therefore, useful in diagnosis and treatment of those disorders.
