Beckman Coulter, Inc. · Class II · Cleared Dec 16, 2005
| K-number | K053090 |
| Device name | DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR |
| Applicant | Beckman Coulter, Inc. |
| Product code | JFM |
| Device class | Class II |
| Decision date | Dec 16, 2005 |
| Decision | Substantially Equivalent |
| Regulation | 862.1110 |
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