← Product Code [CDM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDM) · K821799

# FITKIT I CHECKUP KIT (K821799)

_Patton, Boggs & Blow · CDM · Aug 16, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDM/K821799

## Device Facts

- **Applicant:** Patton, Boggs & Blow
- **Product Code:** [CDM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDM.md)
- **Decision Date:** Aug 16, 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/K821799](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDM/K821799)

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