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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
510(k) Number K253573
Device Name ASTar BC G- Kit
Applicant
Q-Linea AB
Dag Hammarskjölds Väg 52 A
Uppsala,  SE SE 75237
Applicant Contact Camilla Russell
Correspondent
Q-Linea AB
Dag Hammarskjölds Väg 52 A
Uppsala,  SE SE 75237
Correspondent Contact Camilla Russell
Classification Product Code
SAN  
Subsequent Product Code
LON  
Date Received11/17/2025
Decision Date 04/15/2026
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		 Yes
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