← Product Code [CJY](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY) · K922835

# CALCIUM (AZ III) REAGENT (K922835)

_King Diagnostics, Inc. · CJY · Aug 4, 1992 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K922835

## Device Facts

- **Applicant:** King Diagnostics, Inc.
- **Product Code:** [CJY](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY.md)
- **Decision Date:** Aug 4, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1145
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K922835](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K922835)

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