The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Cyto-stat/coulter Clone Cd3-ecd/t4-rd1/t8-fitc Monoclonal Antiboey Reagent.
| Device ID | K950742 |
| 510k Number | K950742 |
| Device Name: | CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT |
| Classification | Counter, Differential Cell |
| Applicant | COULTER CORP. 11800 S.W. 147TH AVE. MAIL CODE 31-B06 Miami, FL 33196 -2500 |
| Contact | Benita B Bourque |
| Correspondent | Benita B Bourque COULTER CORP. 11800 S.W. 147TH AVE. MAIL CODE 31-B06 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 | 1995-02-17 |
| Decision Date | 1995-08-25 |