CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES

Counter, Differential Cell

DAKOCYTOMATION CALIFORNIA, INC.

The following data is part of a premarket notification filed by Dakocytomation California, Inc. with the FDA for Cyan Dxd, Multitest Cd8/cd4/cd3, Cd3-fitc, Cd3-rpe, Cd3-apc And Fluorospheres.

Pre-market Notification Details

Device IDK060423
510k NumberK060423
Device Name:CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES
ClassificationCounter, Differential Cell
Applicant DAKOCYTOMATION CALIFORNIA, INC. 6392 VIA REAL Carpinteria,  CA  93013
ContactTiffany D Almeroth
CorrespondentTiffany D Almeroth
DAKOCYTOMATION CALIFORNIA, INC. 6392 VIA REAL Carpinteria,  CA  93013
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-17
Decision Date2006-08-15
Summary:summary

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