← Product Code [JME](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JME) · K782143

# RIA KIT, GLUCOSE (K782143)

_Serono Laboratories, Inc. · JME · Feb 22, 1979 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JME/K782143

## Device Facts

- **Applicant:** Serono Laboratories, Inc.
- **Product Code:** [JME](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JME.md)
- **Decision Date:** Feb 22, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1335
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A glucagon test system is a device intended to measure the pancreatic hormone glucagon in plasma and serum. Glucagon measurements are used in the diagnosis and treatment of patients with various disorders of carbohydrate metabolism, including diabetes mellitus, hypoglycemia, and hyperglycemia.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JME/K782143](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JME/K782143)

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