FDA 510(k) Application Details - K021582

Device Classification Name Susceptibility Test Powders, Antimycobacterial

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510(K) Number K021582
Device Name Susceptibility Test Powders, Antimycobacterial
Applicant BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS, MD 21152-0999 US
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Contact MICHELLE B BANDY
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Regulation Number 866.1640

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Classification Product Code MJA
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Date Received 05/14/2002
Decision Date 07/13/2002
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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