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510(k) K083572

BD BACTEC Plus Aerobic/F Culture Vials by Becton, Dickinson & CO — Product Code MDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 2008
Date Received
December 3, 2008
Clearance Type
Special
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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