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510(k) K113558

BD BACTEC Plus Aerobic/F Culture Vials (plastic) by Becton, Dickinson and Company — Product Code MDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2012
Date Received
December 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Blood Culturing
Device Class
Class I
Regulation Number
866.2560
Review Panel
MI
Submission Type

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