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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 K200308
Device Name MTS Lefamulin 0.016- 256 µg/mL
Liofilchem s. r. 1.
Via Scozia zona ind.le
Roseto degli Abruzzi,  IT 64026
Applicant Contact Fabio Brocco
Laboratory Specialists, Inc
26214 Center Ridge Road
Westlake,  OH  44145
Correspondent Contact Anne R Windau
Regulation Number866.1640
Classification Product Code
Date Received02/06/2020
Decision Date 04/06/2020
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