← Product Code [KQN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KQN) · K854245

# SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV (K854245)

_Sigma Diagnostics, Inc. · KQN · Jan 22, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KQN/K854245

## Device Facts

- **Applicant:** Sigma Diagnostics, Inc.
- **Product Code:** [KQN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KQN.md)
- **Decision Date:** Jan 22, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1090
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An angiotensin converting enzyme (A.C.E.) test system is a device intended to measure the activity of angiotensin converting enzyme in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher's disease, a hereditary disorder affecting the spleen.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KQN/K854245](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KQN/K854245)

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