The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Tetraone System For Epics Xl Flow Cytometry Systems And Cyto-stat Tertrachrome Cd45-fitc/cd4-rdi/cd8-ecd/cd3-pc5.
| Device ID | K963263 |
| 510k Number | K963263 |
| Device Name: | TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5 |
| Classification | Counter, Differential Cell |
| Applicant | COULTER CORP. 11800 S.W. 147TH AVE. Miami, FL 33196 -2500 |
| Contact | Thoams J English |
| Correspondent | Thoams J English COULTER CORP. 11800 S.W. 147TH AVE. Miami, FL 33196 -2500 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-20 |
| Decision Date | 1997-01-22 |
| Summary: | summary |