← Product Code [KQO](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO) · K870526

# SUPER URINE ANALYZER SYSTEM (K870526)

_Kyoto Daiichi Kagaku Co., Ltd. · KQO · Mar 6, 1987 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO/K870526

## Device Facts

- **Applicant:** Kyoto Daiichi Kagaku Co., Ltd.
- **Product Code:** [KQO](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO.md)
- **Decision Date:** Mar 6, 1987
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO/K870526](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO/K870526)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
