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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 K982519
Device Name LEVOFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
Applicant
Oxoid , Ltd.
Wade Rd.
Basingstoke,  GB RG24 8PW
Applicant Contact ANDY HOLLINGSWORTH
Correspondent
Oxoid , Ltd.
Wade Rd.
Basingstoke,  GB RG24 8PW
Correspondent Contact ANDY HOLLINGSWORTH
Regulation Number866.1620
Classification Product Code
JTN  
Date Received07/20/1998
Decision Date 09/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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