FDA 510(k) Application Details - K152516

Device Classification Name Susceptibility Test Discs, Antimicrobial

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510(K) Number K152516
Device Name Susceptibility Test Discs, Antimicrobial
Applicant BECTON, DICKINSON AND COMPANY
7 LOVETON CIRCLE
SPARKS, MD 21152-0999 US
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Contact LAURA STEWART
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Regulation Number 866.1620

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Classification Product Code JTN
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Date Received 09/03/2015
Decision Date 10/13/2015
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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