OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES

Counter, Differential Cell

IMMUNOTECH CORP.

The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Opticlone Cd3/cd4 Monoclonal Antibodies.

Pre-market Notification Details

Device IDK950626
510k NumberK950626
Device Name:OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES
ClassificationCounter, Differential Cell
Applicant IMMUNOTECH CORP. 160 B LARRABEE RD. Westbrook,  ME  04092
ContactJames W Champlin
CorrespondentJames 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 Received1995-02-10
Decision Date1995-05-05

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