IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
Device Facts
| Record ID | K011505 |
|---|---|
| Device Name | IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6 |
| Applicant | Diagnostic Products Corp. |
| Product Code | CEW · Clinical Chemistry |
| Decision Date | Jul 2, 2001 |
| 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.
