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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Antimicrobial Susceptibility Test Systems
510(k) Number K190252
Device Name MTS Gentamicin 0.016 - 256 µg/mL
Applicant
Liofilchem S. R. L.
Via Scozia Zona Ind Le
Roseto Degli Abruzzi,  IT 64026
Applicant Contact Fabio Brocco
Correspondent
Laboratory Specialists, Inc.
26214 Center Ridge Rd.
Westlake,  OH  44145
Correspondent Contact Anne R. Windau
Regulation Number866.1640
Classification Product Code
JWY  
Date Received02/07/2019
Decision Date 03/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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