FDA 510(k) Application Details - K063573

Device Classification Name System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

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510(K) Number K063573
Device Name System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BECTON DICKINSON & CO.
7 LOVETON CIR.
SPARKS, MD 21152 US
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Contact VICKI KENNEDY WHITLEY
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Regulation Number 866.1645

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Classification Product Code LON
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Date Received 11/29/2006
Decision Date 01/11/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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