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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 K193508
Device Name Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20
Applicant
Oxoid Limited (Part of Thermo Fisher Scientific)
Wade Rd.
Basingstoke,  GB RG24 8PW
Applicant Contact Philip Brame
Correspondent
Oxoid Limited (Part of Thermo Fisher Scientific)
Wade Rd.
Basingstoke,  GB RG24 8PW
Correspondent Contact Philip Brame
Regulation Number866.1620
Classification Product Code
JTN  
Date Received12/18/2019
Decision Date 12/04/2020
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
Predetermined Change
Control Plan Authorized		 No
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