← Product Code [MQM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM) · K922770

# UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 (K922770)

_Leica, Inc. · MQM · Aug 18, 1992 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K922770

## Device Facts

- **Applicant:** Leica, Inc.
- **Product Code:** [MQM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM.md)
- **Decision Date:** Aug 18, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1113
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K922770](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K922770)

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