CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554

Counter, Differential Cell

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Cytomics Fc 500 Mpl Flow Cytometer, Model # 626554.

Pre-market Notification Details

Device IDK071681
510k NumberK071681
Device Name:CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
ClassificationCounter, Differential Cell
Applicant BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami,  FL  33196 -2500
ContactLourdes Coba
CorrespondentLourdes Coba
BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami,  FL  33196 -2500
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-19
Decision Date2007-10-04
Summary:summary

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