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510(k) K120994

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2012
Date Received
April 2, 2012
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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