← Product Code [JIL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL) · K010973

# DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000 (K010973)

_Hypoguard USA, Inc. · JIL · Sep 11, 2001 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K010973

## Device Facts

- **Applicant:** Hypoguard USA, Inc.
- **Product Code:** [JIL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL.md)
- **Decision Date:** Sep 11, 2001
- **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/JIL/K010973](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K010973)

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