PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463
Device Facts
| Record ID | K901964 |
|---|---|
| Device Name | PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463 |
| Applicant | American Research Products Co. |
| Product Code | CEO · Clinical Chemistry |
| Decision Date | May 31, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1580 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
