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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 K211815
Device Name LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
Applicant
Affinity Biosensors
222 East Canon Perdido Street Suite 101
Santa Barbara,  CA  93101
Applicant Contact Ken Babcock
Correspondent
MDC Associates, Inc.
48 Dunham Ridge
Suite 4000
Beverly,  MA  01915
Correspondent Contact Peter Trabold
Regulation Number866.1650
Classification Product Code
SAN  
Subsequent Product Code
LON  
Date Received06/11/2021
Decision Date 04/02/2024
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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