FDA 510(k) Application Details - K140448

Device Classification Name Dna-Reagents, Neisseria

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510(K) Number K140448
Device Name Dna-Reagents, Neisseria
Applicant BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS, MD 21152-0999 US
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Contact SHERMA WINSTON
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Regulation Number 866.3390

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Classification Product Code LSL
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Date Received 02/21/2014
Decision Date 05/20/2014
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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