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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
510(k) Number K181599
Device Name Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
Applicant
Beckman Coulter
11800 SW 147th Ave.
Miami,  FL  33196
Applicant Contact Radha Goolabsingh
Correspondent
Beckman Coulter
11800 SW 147th Ave.
Miami,  FL  33196
Correspondent Contact Radha Goolabsingh
Regulation Number866.3215
Classification Product Code
QFS  
Subsequent Product Code
GKZ  
Date Received06/18/2018
Decision Date 03/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT03145428
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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