Abbott Laboratories · Class II · Cleared Jun 6, 2001
| K-number | K010953 |
| Device name | CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY |
| Applicant | Abbott Laboratories |
| Product code | GKZ |
| Device class | Class II |
| Decision date | Jun 6, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 864.5220 |
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