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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 K211759
Device Name Selux AST System; Model AST Gen 1.0
Applicant
Selux Diagnostics, Inc.
56 Roland St.
Suite 206
Charlestown,  MA  02129
Applicant Contact Eric Stern
Correspondent
Pbo Consulting
2212 E. Pratt St.
Baltimore,  MD  21231
Correspondent Contact Patricia Shrader
Regulation Number866.1645
Classification Product Code
LON  
Subsequent Product Codes
LTT   LTW  
Date Received06/07/2021
Decision Date 01/18/2023
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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