MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE

Counter, Differential Cell

DAKO CORP.

The following data is part of a premarket notification filed by Dako Corp. with the FDA for Mouse Anti-human Cd3, T-cell, Fitc & Cd8, T-cell(suppressor/cytotoxic) Rpe.

Pre-market Notification Details

Device IDK955909
510k NumberK955909
Device Name:MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE
ClassificationCounter, Differential Cell
Applicant DAKO CORP. 6392 VIA REAL Carpinteria,  CA  93013
ContactGretchen M Murray
CorrespondentGretchen M Murray
DAKO CORP. 6392 VIA REAL Carpinteria,  CA  93013
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-29
Decision Date1996-03-28
Summary:summary

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