Beckman Coulter, Inc. · Class II · Cleared Jan 17, 2003
| K-number | K030012 |
| Device name | CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 |
| Applicant | Beckman Coulter, Inc. |
| Product code | JHX |
| Device class | Class II |
| Decision date | Jan 17, 2003 |
| Decision | Substantially Equivalent |
| Regulation | 862.1215 |
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