← Product Code [KQO](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO) · K954158

# STC DIAGNOSTICS AUTO-LYTE PH ASSAY (K954158)

_Solarcare Technologies Corp,Inc. · KQO · Apr 30, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO/K954158

## Device Facts

- **Applicant:** Solarcare Technologies Corp,Inc.
- **Product Code:** [KQO](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO.md)
- **Decision Date:** Apr 30, 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/K954158](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO/K954158)

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