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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 K221688
Device Name ASTar BC G- Kit and ASTar Instrument
Applicant
Q-Linea AB
Dag Hammarskjolds Vag 52a
Uppsala,  SE SE 75237
Applicant Contact Jonas Melin
Correspondent
MDC Associates, Inc.
48 Dunham Ridge Rd.
Suite 4000
Beverly,  MA  01915
Correspondent Contact Peter Trabold
Classification Product Code
SAN  
Subsequent Product Code
LON  
Date Received06/10/2022
Decision Date 04/26/2024
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
Predetermined Change
Control Plan Authorized		 No
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