PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION
Device Facts
| Record ID | K870368 |
|---|---|
| Device Name | PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION |
| Applicant | Trace Scientific , Ltd. |
| Product Code | CEO · Clinical Chemistry |
| Decision Date | Aug 19, 1987 |
| 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.
