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510(k) K123903

BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) by Becton, Dickinson & CO — Product Code MDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2013
Date Received
December 19, 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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