510(k) K173873

BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial by Becton, Dickinson and Company — Product Code MDB

K173873 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial". The FDA issued a decision of Substantially Equivalent on March 16, 2018. The device falls under product code MDB (System, Blood Culturing), a Class I device regulated under 21 CFR 866.2560. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2018
Date Received
December 20, 2017
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