← Product Code [JKR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKR) · K961043

# SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY) (K961043)

_Scantibodies Laboratory, Inc. · JKR · May 6, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKR/K961043

## Device Facts

- **Applicant:** Scantibodies Laboratory, Inc.
- **Product Code:** [JKR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKR.md)
- **Decision Date:** May 6, 1996
- **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/K961043](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKR/K961043)

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