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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 K251875
Device Name LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
Applicant
Affinity Biosensors, LLC
222 E. Canon Perdido St.
Santa Barbara,  CA  93101
Applicant Contact Ken Babcock
Correspondent
Affinity Biosensors, LLC
222 E. Canon Perdido St.
Santa Barbara,  CA  93101
Correspondent Contact Nicole Holliday
Classification Product Code
SAN  
Subsequent Product Code
LON  
Date Received06/18/2025
Decision Date 10/27/2025
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		 Yes
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