FLAME PHOTOMETER, MODEL 435
Device Facts
| Record ID | K780649 |
|---|---|
| Device Name | FLAME PHOTOMETER, MODEL 435 |
| Applicant | Corning Medical & Scientific |
| Product Code | JJO · Clinical Chemistry |
| Decision Date | May 26, 1978 |
| 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.
