HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196
Device Facts
| Record ID | K890773 |
|---|---|
| Device Name | HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196 |
| Applicant | Hichem Diagnostics |
| Product Code | CEO · Clinical Chemistry |
| Decision Date | Apr 18, 1989 |
| 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.