← Product Code [JIM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIM) · K902155

# HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) (K902155)

_Hichem Diagnostics · JIM · Jun 12, 1990 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIM/K902155

## Device Facts

- **Applicant:** Hichem Diagnostics
- **Product Code:** [JIM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIM.md)
- **Decision Date:** Jun 12, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1340
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders 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/JIM/K902155](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIM/K902155)

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