| K-number | K222996 |
| Device name | Access PCT |
| Applicant | Beckman Coulter, Inc. |
| Product code | PTF |
| Device class | Class II |
| Decision date | Apr 26, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 866.3215 |
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View the full FDA submission: accessdata.fda.gov