BD MAX Extended Enteric Bacterial Panel, BD MAX System
K-Number: K170308 · 2017-05-02
ApplicantBecton, Dickinson and Company
Decision Date2017-05-02
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
BD MAX Extended Enteric Bacterial Panel, BD MAX System is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2017-05-02 under approval number K170308. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BD MAX Extended Enteric Bacterial Panel, BD MAX System?
BD MAX Extended Enteric Bacterial Panel, BD MAX System is a medical device that received FDA 510(k) clearance on 2017-05-02. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K170308.
When was BD MAX Extended Enteric Bacterial Panel, BD MAX System approved by the FDA?
BD MAX Extended Enteric Bacterial Panel, BD MAX System received FDA 510(k) clearance on 2017-05-02, under approval number K170308.
What company makes BD MAX Extended Enteric Bacterial Panel, BD MAX System?
BD MAX Extended Enteric Bacterial Panel, BD MAX System is manufactured by Becton, Dickinson and Company.
What is the FDA product code for BD MAX Extended Enteric Bacterial Panel, BD MAX System?
The FDA product code for BD MAX Extended Enteric Bacterial Panel, BD MAX System is PCH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.