← Product Code [CDM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDM) · K831623

# DIA STRIPS SYSTEM (K831623)

_California Immuno Diagnostic, Inc. · CDM · Jul 28, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDM/K831623

## Device Facts

- **Applicant:** California Immuno Diagnostic, Inc.
- **Product Code:** [CDM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDM.md)
- **Decision Date:** Jul 28, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1785
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDM/K831623](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDM/K831623)

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