← Product Code [JME](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JME) · K893975

# DOUBLE ANTIBODY GLUCAGON (K893975)

_Diagnostic Products Corp. · JME · Oct 31, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JME/K893975

## Device Facts

- **Applicant:** Diagnostic Products Corp.
- **Product Code:** [JME](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JME.md)
- **Decision Date:** Oct 31, 1989
- **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/K893975](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JME/K893975)

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