Beckman Coulter, Inc. · Class II · Cleared Dec 29, 2003
| K-number | K033038 |
| Device name | GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 |
| Applicant | Beckman Coulter, Inc. |
| Product code | NIG |
| Device class | Class II |
| Decision date | Dec 29, 2003 |
| Decision | Substantially Equivalent |
| Regulation | 866.6010 |
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