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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 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 2018-11-29 under 510(k) 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. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K181427.

When did BD MAX Enteric Viral Panel, BD MAX Instrument receive FDA 510(k) clearance?

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

Who is the listed applicant for BD MAX Enteric Viral Panel, BD MAX Instrument?

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 Enteric Viral Panel, BD MAX Instrument?

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

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