← Product Code [CEW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW) · K001411

# WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056 (K001411)

_Scantibodies Laboratory, Inc. · CEW · Aug 21, 2000 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW/K001411

## Device Facts

- **Applicant:** Scantibodies Laboratory, Inc.
- **Product Code:** [CEW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW.md)
- **Decision Date:** Aug 21, 2000
- **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/K001411](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW/K001411)

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