← Product Code [CFP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP) · K771947

# INSULIN RIA MODULE (K771947)

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

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K771947

## Device Facts

- **Applicant:** Inter Science Institute
- **Product Code:** [CFP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP.md)
- **Decision Date:** Jan 20, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1405
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and plasma. Immunoreactive insulin measurements are used in the diagnosis and treatment of various carbohydrate metabolism disorders, including diabetes mellitus, and hypoglycemia.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K771947](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K771947)

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