Beckman Coulter, Inc. · Class II · Cleared Sep 7, 2001
| K-number | K012208 |
| Device name | ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 |
| Applicant | Beckman Coulter, Inc. |
| Product code | DDC |
| Device class | Class II |
| Decision date | Sep 7, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 866.5870 |
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