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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Susceptibility Test Discs, Antimicrobial
510(k) Number K251879
Device Name Sulopenem SPM 2 µg
Applicant
Liofilchem
465 Waverley Oaks Rd.
Suite 317
Waltham,  MA  02452
Applicant Contact Emily Hodgkins
Correspondent
Liofilchem
465 Waverley Oaks Rd.
Suite 317
Waltham,  MA  02452
Correspondent Contact Emily Hodgkins
Regulation Number866.1620
Classification Product Code
JTN  
Date Received06/18/2025
Decision Date 08/12/2025
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		 Yes
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