Beckman Coulter, Inc. · Class II · Cleared Feb 3, 2004
| K-number | K033036 |
| Device name | BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 |
| Applicant | Beckman Coulter, Inc. |
| Product code | MOI |
| Device class | Class II |
| Decision date | Feb 3, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 866.6010 |
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