← Product Code [JKR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKR) · K914429

# DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) (K914429)

_Diagnostic Systems Laboratories, Inc. · JKR · Jan 15, 1992 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKR/K914429

## Device Facts

- **Applicant:** Diagnostic Systems Laboratories, Inc.
- **Product Code:** [JKR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKR.md)
- **Decision Date:** Jan 15, 1992
- **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/K914429](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKR/K914429)

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