| K-number | K021150 |
| Device name | COULTER CELLPREP |
| Applicant | Beckman Coulter, Inc. |
| Product code | GKH |
| Device class | Class I |
| Decision date | Jun 11, 2002 |
| Decision | Substantially Equivalent |
| Regulation | 864.5240 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov