| K-number | K223289 |
| Device name | Access Vitamin B12 |
| Applicant | Beckman Coulter, Inc. |
| Product code | CDD |
| Device class | Class II |
| Decision date | Dec 23, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 862.1810 |
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View the full FDA submission: accessdata.fda.gov