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FDA 510(k)

BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel

K-Number: K214122 · 2022-07-28

ApplicantBecton, Dickinson and Company
Decision Date2022-07-28
Product CodePCI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2022-07-28 under approval number K214122. The device is classified under product code PCI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel?

BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel is a medical device that received FDA 510(k) clearance on 2022-07-28. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K214122.

When was BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel approved by the FDA?

BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel received FDA 510(k) clearance on 2022-07-28, under approval number K214122.

What company makes BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel?

BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel?

The FDA product code for BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel is PCI.

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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.

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