← Product Code [CEW](/productcode/CEW) · K791128

# PTH RIA 200 (K791128)

_Institut National Des Radioelements · CEW · Sep 27, 1979 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K791128

## Device Facts

- **Applicant:** Institut National Des Radioelements
- **Product Code:** [CEW](/productcode/CEW.md)
- **Decision Date:** Sep 27, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1545
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/device/K791128](https://fda.innolitics.com/device/K791128)

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