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 |