← Product Code [KQO](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO) · K842237

# CLINITEK 200 SEMI-AUTOMATED URINALYSIS (K842237)

_Miles Laboratories, Inc. · KQO · Aug 15, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO/K842237

## Device Facts

- **Applicant:** Miles Laboratories, Inc.
- **Product Code:** [KQO](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO.md)
- **Decision Date:** Aug 15, 1984
- **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/K842237](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO/K842237)

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