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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
510(k) Number K201405
Device Name LabPro Data Management System
Applicant
Beckman Coulter, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact Christina Thomas
Correspondent
Beckman Coulter, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact Christina Thomas
Regulation Number866.1645
Classification Product Code
LON  
Date Received05/28/2020
Decision Date 08/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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