UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0

Glucose Oxidase, Glucose

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Unicel Dxc 600 Synchron System Software Version 5.0 And Unicel Dxc 800 Synchron System Software Version 5.0.

Pre-market Notification Details

Device IDK103842
510k NumberK103842
Device Name:UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
ClassificationGlucose Oxidase, Glucose
Applicant BECKMAN COULTER, INC. 250 S. KRAEMER BOULEVARD MAIL STOP E2 SE08 Brea,  CA  92821
ContactMarine Boyajian
CorrespondentMarine Boyajian
BECKMAN COULTER, INC. 250 S. KRAEMER BOULEVARD MAIL STOP E2 SE08 Brea,  CA  92821
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-30
Decision Date2011-04-27
Summary:summary

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