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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
510(k) Number K244044
Device Name PBC Separator with Selux AST System
Applicant
Selux Diagnostics, Inc.
56 Roland Street, Suite 206
Charlestown,  MA  02129
Applicant Contact Carrene Plummer
Correspondent
Selux Diagnostics, Inc.
56 Roland Street, Suite 206
Charlestown,  MA  02129
Correspondent Contact Carrene Plummer
Classification Product Code
QZX  
Subsequent Product Codes
LON   LTT   LTW  
Date Received12/30/2024
Decision Date 03/28/2025
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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