510(k) K141810

BD BACTEC PLUS ANAEROBIC/F (PLASTIC) by Becton, Dickinson and Company — Product Code MDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2014
Date Received
July 7, 2014
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