← Product Code [KQO](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO) · K954156

# STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY (K954156)

_Solarcare Technologies Corp,Inc. · KQO · Jul 22, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO/K954156

## Device Facts

- **Applicant:** Solarcare Technologies Corp,Inc.
- **Product Code:** [KQO](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO.md)
- **Decision Date:** Jul 22, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2900
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO/K954156](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO/K954156)

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