← Product Code [JIN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIN) · K850368

# SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV (K850368)

_Sigma Chemical Co. · JIN · Aug 30, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIN/K850368

## Device Facts

- **Applicant:** Sigma Chemical Co.
- **Product Code:** [JIN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIN.md)
- **Decision Date:** Aug 30, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1435
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIN/K850368](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIN/K850368)

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