The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Cyto-stat Tetrachrome Cd45-fit/cd4-pe/cd3-pc5 Monoclonal Antibody Reagent, Cyto-stat Tetrachrom Cd45-fitc/cd56-pe/cd19-a.
| Device ID | K030408 |
| 510k Number | K030408 |
| Device Name: | CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A |
| Classification | Counter, Differential Cell |
| Applicant | BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami, FL 33196 -2500 |
| Contact | Stan Sugrue |
| Correspondent | Stan Sugrue BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami, FL 33196 -2500 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-07 |
| Decision Date | 2003-03-04 |
| Summary: | summary |