COLORMATE TLC BILITEST SYSTEM
Device Facts
| Record ID | K001687 |
|---|---|
| Device Name | COLORMATE TLC BILITEST SYSTEM |
| Applicant | Chromatics Color Sciences Intl., Inc. |
| Product Code | MQM · Clinical Chemistry |
| Decision Date | Sep 13, 2001 |
| 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).
