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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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More FDA Info for this Product Code
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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