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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
510(k) Number K092767
Device Name BBL CHROMAGAR MRSA II
Applicant
Becton, Dickinson & CO
7loveton Cir.
Sparks,  MD  21152
Applicant Contact Paul Swift
Correspondent
Becton, Dickinson & CO
7loveton Cir.
Sparks,  MD  21152
Correspondent Contact Paul Swift
Regulation Number866.1700
Classification Product Code
JSO  
Date Received09/09/2009
Decision Date 08/20/2010
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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