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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2017-05-02 under 510(k) 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. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K170308.

When did BD MAX Extended Enteric Bacterial Panel, BD MAX System receive FDA 510(k) clearance?

BD MAX Extended Enteric Bacterial Panel, BD MAX System received FDA 510(k) clearance on 2017-05-02, under 510(k) number K170308.

Who is the listed applicant for BD MAX Extended Enteric Bacterial Panel, BD MAX System?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: 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.

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