RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER
Device Facts
| Record ID | K010052 |
|---|---|
| Device Name | RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER |
| Applicant | Respironics, Inc. |
| Product Code | MQM · Clinical Chemistry |
| Decision Date | Mar 19, 2001 |
| Decision | SESE |
| Submission Type | Abbreviated |
| 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).
