The following data is part of a premarket notification filed by Intracel Corp. with the FDA for Zymmune(tm) Cd4/cd8 Cell Monitoring Kit.
| Device ID | K933878 |
| 510k Number | K933878 |
| Device Name: | ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT |
| Classification | Counter, Differential Cell |
| Applicant | INTRACEL CORP. 359 ALLSTON ST. Cambridge, MA 02139 |
| Contact | Cynthia A Sinclair |
| Correspondent | Cynthia A Sinclair INTRACEL CORP. 359 ALLSTON ST. Cambridge, MA 02139 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-09 |
| Decision Date | 1995-11-14 |