The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Opticlone Igg1 Fitc/igg2a Pe Isotypic Control.
| Device ID | K954188 |
| 510k Number | K954188 |
| Device Name: | OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL |
| Classification | Counter, Differential Cell |
| Applicant | IMMUNOTECH CORP. 160 B LARRABEE RD. Westbrook, ME 04092 |
| Contact | Jamees W Champlin |
| Correspondent | Jamees 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 | 1995-09-06 |
| Decision Date | 1995-11-03 |