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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 K223493
Device Name PBC Separator with Selux AST System
Applicant
Selux Diagnostics, Inc
56 Roland St, Suite 206
Charlestown,  MA  02129
Applicant Contact Eric Stern
Correspondent
PBO Consulting
2212 East Pratt Street
Baltimore,  MD  21231
Correspondent Contact Carrene Plummer
Regulation Number866.1650
Classification Product Code
QZX  
Subsequent Product Codes
LON   LTT   LTW  
Date Received11/21/2022
Decision Date 02/15/2024
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
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