OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL

Counter, Differential Cell

IMMUNOTECH CORP.

The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Opticlone Igg1 Fitc/igg2a Pe Isotypic Control.

Pre-market Notification Details

Device IDK954188
510k NumberK954188
Device Name:OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL
ClassificationCounter, Differential Cell
Applicant IMMUNOTECH CORP. 160 B LARRABEE RD. Westbrook,  ME  04092
ContactJamees W Champlin
CorrespondentJamees W Champlin
IMMUNOTECH CORP. 160 B LARRABEE RD. Westbrook,  ME  04092
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-06
Decision Date1995-11-03

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