The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Opticlone Cd4fitc/cd8 Pe Monoclonal Antibodies.
| Device ID | K952789 |
| 510k Number | K952789 |
| Device Name: | OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES |
| Classification | Counter, Differential Cell |
| Applicant | IMMUNOTECH CORP. 160 B LARRABEE RD. Westbrook, ME 04092 |
| Contact | James W Champlin |
| Correspondent | James W Champlin IMMUNOTECH CORP. 160 B LARRABEE RD. Westbrook, ME 04092 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-19 |
| Decision Date | 1995-08-14 |