← Product Code [CEW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW) · K962598

# NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT (K962598)

_Nichols Institute Diagnostics · CEW · Dec 10, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW/K962598

## Device Facts

- **Applicant:** Nichols Institute Diagnostics
- **Product Code:** [CEW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW.md)
- **Decision Date:** Dec 10, 1996
- **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/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW/K962598](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW/K962598)

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