FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
Device Facts
| Record ID | K000471 |
|---|---|
| Device Name | FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT |
| Applicant | Future Diagnostics B.V. |
| Product Code | CEW · Clinical Chemistry |
| Decision Date | Apr 11, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1545 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.
