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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 K230479
Device Name ComASP Cefiderocol 0.008-128
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 Road
Westlake,  OH  44145
Correspondent Contact Laura Koeth
Regulation Number866.1640
Classification Product Code
JWY  
Subsequent Product Code
LTT  
Date Received02/22/2023
Decision Date 05/18/2023
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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