FDA 510(k) Application Details - K140111

Device Classification Name

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510(K) Number K140111
Device Name BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT
Applicant Becton, Dickinson and Company
7 LOVETON CIRCLE
SPARKS, MD 21152 US
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Contact Paul Swift
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Regulation Number

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Classification Product Code PCI
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Date Received 01/15/2014
Decision Date 05/06/2014
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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