← Product Code [JKR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKR) · K912536

# CALCITONIN KIT MITSUBISHI YUKA (K912536)

_Mitsubishi Yuka America, Inc. · JKR · Jul 18, 1991 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKR/K912536

## Device Facts

- **Applicant:** Mitsubishi Yuka America, Inc.
- **Product Code:** [JKR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKR.md)
- **Decision Date:** Jul 18, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1140
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKR/K912536](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKR/K912536)

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