Beckman Coulter, Inc. · Class II · Cleared Jun 28, 2002
| K-number | K021229 |
| Device name | MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 |
| Applicant | Beckman Coulter, Inc. |
| Product code | DDR |
| Device class | Class II |
| Decision date | Jun 28, 2002 |
| Decision | Substantially Equivalent |
| Regulation | 866.5680 |
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