← Product Code [CJY](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY) · K770817

# ULTRACHEM CALCIUM (K770817)

_Harleco · CJY · Jul 11, 1977 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K770817

## Device Facts

- **Applicant:** Harleco
- **Product Code:** [CJY](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY.md)
- **Decision Date:** Jul 11, 1977
- **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/K770817](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K770817)

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