| K-number | K111143 |
| Device name | POLY-CHEM 90 TOTAL BILIRUBIN |
| Applicant | Polymedco, Inc. |
| Product code | CIG |
| Device class | Class II |
| Decision date | Sep 1, 2011 |
| Decision | Substantially Equivalent |
| Regulation | 862.1110 |
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