← Product Code [CIG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG) · K902123

# SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406 (K902123)

_Em Diagnostic Systems, Inc. · CIG · Jun 6, 1990 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG/K902123

## Device Facts

- **Applicant:** Em Diagnostic Systems, Inc.
- **Product Code:** [CIG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG.md)
- **Decision Date:** Jun 6, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1110
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG/K902123](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG/K902123)

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