The following data is part of a premarket notification filed by Immunotech, Inc. with the FDA for Opticlone Igg1 Fitc/igg1 Pe Isotypic Control.
| Device ID | K953498 |
| 510k Number | K953498 |
| Device Name: | OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL |
| Classification | Counter, Differential Cell |
| Applicant | IMMUNOTECH, INC. 160-B LARRABEE RD. Westbrook, ME 04092 |
| Contact | James W Champlin |
| Correspondent | James W Champlin IMMUNOTECH, INC. 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 | 1995-07-26 |
| Decision Date | 1995-09-08 |