FDA 510(k) Application Details - K112586

Device Classification Name Susceptibility Test Discs, Antimicrobial

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510(K) Number K112586
Device Name Susceptibility Test Discs, Antimicrobial
Applicant BECTON DICKINSON AND COMPANY (BD)
7 LOVETON CIRCLE
MC 614
SPARKS, MD 21152 US
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Contact KATIE COYLE
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Regulation Number 866.1620

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Classification Product Code JTN
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Date Received 09/06/2011
Decision Date 10/18/2011
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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