UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311
Device Facts
| Record ID | K922770 |
|---|---|
| Device Name | UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 |
| Applicant | Leica, Inc. |
| Product Code | MQM · Clinical Chemistry |
| Decision Date | Aug 18, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1113 |
| Device Class | Class 1 |
Regulatory Classification
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).
