← Product Code [JME](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JME) · K771948

# GLUCAGON RIA MODULE (K771948)

_Inter Science Institute · JME · Jan 20, 1978 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JME/K771948

## Device Facts

- **Applicant:** Inter Science Institute
- **Product Code:** [JME](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JME.md)
- **Decision Date:** Jan 20, 1978
- **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/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JME/K771948](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JME/K771948)

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