← Product Code [CIB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB) · K831694

# RENAK (K831694)

_Hoffmann-La Roche, Inc. · CIB · Jul 19, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K831694

## Device Facts

- **Applicant:** Hoffmann-La Roche, Inc.
- **Product Code:** [CIB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB.md)
- **Decision Date:** Jul 19, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1085
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An angiotensin I and renin test system is a device intended to measure the level of angiotensin I generated by renin in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K831694](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K831694)

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