LabPro Data Management System

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Beckman Coulter Inc.

The following data is part of a premarket notification filed by Beckman Coulter Inc. with the FDA for Labpro Data Management System.

Pre-market Notification Details

Device IDK201405
510k NumberK201405
Device Name:LabPro Data Management System
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant Beckman Coulter Inc. 1584 Enterprise Blvd West Sacramento,  CA  95691
ContactChristina Thomas
CorrespondentChristina Thomas
Beckman Coulter Inc. 1584 Enterprise Blvd West Sacramento,  CA  95691
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-28
Decision Date2020-08-30

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