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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
Applicant
Liofilchem s. r. 1.
Via Scozia zona ind.le
Roseto degli Abruzzi,  IT 64026
Applicant Contact Fabio Brocco
Correspondent
Laboratory Specialists, Inc
26214 Center Ridge Road
Westlake,  OH  44145
Correspondent Contact Anne R Windau
Regulation Number866.1640
Classification Product Code
JWY  
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
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