Coulter Corp. · Class II · Cleared Nov 9, 1998
| K-number | K982167 |
| Device name | CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 |
| Applicant | Coulter Corp. |
| Product code | GKZ |
| Device class | Class II |
| Decision date | Nov 9, 1998 |
| 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