UNICEL DXH 800 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 800 Coulter Cellular Analysis System.

Pre-market Notification Details

Device IDK081930
510k NumberK081930
Device Name:UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
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)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-07
Decision Date2008-12-19
Summary:summary

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