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 With Cyto-stat Tetrachrome Cd45-fitc/cd4-rd1/cd8-ecd/cd3-pc5 Monocla.
| Device ID | K990172 |
| 510k Number | K990172 |
| Device Name: | TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA |
| Classification | Counter, Differential Cell |
| Applicant | COULTER CORP. 11800 S.W. 147TH AVE. Miami, FL 33196 -2500 |
| Contact | Marion S Gaide |
| Correspondent | Marion S Gaide 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 | 1999-01-19 |
| Decision Date | 1999-04-13 |
| Summary: | summary |