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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 K203336
Device Name Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
Applicant
Oxoid Limited (part of Thermo Fisher Scientific)
Wade Road
Basingstoke,  GB RG24 8PW
Applicant Contact Philip Brame
Correspondent
Oxoid Limited (part of Thermo Fisher Scientific)
Wade Road
Basingstoke,  GB RG24 8PW
Correspondent Contact Amie Lovatt
Regulation Number866.1620
Classification Product Code
JTN  
Date Received11/12/2020
Decision Date 09/15/2022
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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