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FDA 510(k)

BD MAX Enteric Viral Panel, BD MAX Instrument

K-Number: K181427 · 2018-11-29

ApplicantBecton, Dickinson and Company
Decision Date2018-11-29
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD MAX Enteric Viral Panel, BD MAX Instrument is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2018-11-29 under approval number K181427. 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 Enteric Viral Panel, BD MAX Instrument?

BD MAX Enteric Viral Panel, BD MAX Instrument is a medical device that received FDA 510(k) clearance on 2018-11-29. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K181427.

When was BD MAX Enteric Viral Panel, BD MAX Instrument approved by the FDA?

BD MAX Enteric Viral Panel, BD MAX Instrument received FDA 510(k) clearance on 2018-11-29, under approval number K181427.

What company makes BD MAX Enteric Viral Panel, BD MAX Instrument?

BD MAX Enteric Viral Panel, BD MAX Instrument is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD MAX Enteric Viral Panel, BD MAX Instrument?

The FDA product code for BD MAX Enteric Viral Panel, BD MAX Instrument is PCH.

Related Clinical Trials

NCT05708755 CMV Immunity Monitoring in Lung Transplant Recipients RECRUITING

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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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