EMDS PHOSPHOROUS (PHOS) TEST
Device Facts
| Record ID | K935178 |
|---|---|
| Device Name | EMDS PHOSPHOROUS (PHOS) TEST |
| Applicant | Em Diagnostic Systems, Inc. |
| Product Code | CEO · Clinical Chemistry |
| Decision Date | Dec 17, 1993 |
| 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.
