UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System

Counter, Differential Cell

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Unicel Dxh Slidemaker Stainer Coulter Cellular Analysis System.

Pre-market Notification Details

Device IDK162414
510k NumberK162414
Device Name:UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
ClassificationCounter, Differential Cell
Applicant BECKMAN COULTER, INC. 11800 SW 147TH AVE. Miami,  FL  33196
ContactNancy Nadler
CorrespondentNancy Nadler
BECKMAN COULTER, INC. 11800 SW 147TH AVE. Miami,  FL  33196
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-29
Decision Date2016-11-29
Summary:summary

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