FDA 510(k) Application Details - K100722

Device Classification Name Susceptibility Test Discs, Antimicrobial

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510(K) Number K100722
Device Name Susceptibility Test Discs, Antimicrobial
Applicant Becton, Dickinson and Company
7 LOVETON CIRCLE, MC 614
SPARKS, MD 21152 US
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Contact JANINE SPAFFORD
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Regulation Number 866.1620

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Classification Product Code JTN
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Date Received 03/15/2010
Decision Date 03/29/2010
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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