FDA 510(k) Application Details - K946268

Device Classification Name System, Blood Culturing

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510(K) Number K946268
Device Name System, Blood Culturing
Applicant BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
7 LOVETON CIRCLE
SPARKS, MD 21152-0999 US
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Contact DENNIS R MERTZ
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Regulation Number 866.2560

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Classification Product Code MDB
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Date Received 12/23/1994
Decision Date 05/21/1996
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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