Beckman Coulter, Inc. · Class II · Cleared Sep 16, 2014
| K-number | K140496 |
| Device name | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents |
| Applicant | Beckman Coulter, Inc. |
| Product code | CDD |
| Device class | Class II |
| Decision date | Sep 16, 2014 |
| Decision | Substantially Equivalent |
| Regulation | 862.1810 |
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