RAICHEM PHOSPORUS REAGENT
Device Facts
| Record ID | K003012 |
|---|---|
| Device Name | RAICHEM PHOSPORUS REAGENT |
| Applicant | Hemagen Diagnostics, Inc. |
| Product Code | CEO · Clinical Chemistry |
| Decision Date | Oct 25, 2000 |
| Decision | SESE |
| Submission Type | Special |
| 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.
