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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 K050062
Device Name GEMIFLOXACIN, 5UG BBL SENSI-DISC
Applicant
Becton, Dickinson & CO
7loveton Cir.
Sparks,  MD  21152
Applicant Contact BRADFORD SPRING
Correspondent
Becton, Dickinson & CO
7loveton Cir.
Sparks,  MD  21152
Correspondent Contact BRADFORD SPRING
Regulation Number866.1620
Classification Product Code
JTN  
Date Received01/11/2005
Decision Date 02/10/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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