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FDA 510(k)

BD MAX CT/GC/TV, BD MAX INSTRUMENT

K-Number: K151589 · 2016-09-06

ApplicantBecton, Dickinson and Company
Decision Date2016-09-06
Product CodeOUY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BD MAX CT/GC/TV, BD MAX INSTRUMENT is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2016-09-06 under approval number K151589. The device is classified under product code OUY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD MAX CT/GC/TV, BD MAX INSTRUMENT?

BD MAX CT/GC/TV, BD MAX INSTRUMENT is a medical device that received FDA 510(k) clearance on 2016-09-06. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K151589.

When was BD MAX CT/GC/TV, BD MAX INSTRUMENT approved by the FDA?

BD MAX CT/GC/TV, BD MAX INSTRUMENT received FDA 510(k) clearance on 2016-09-06, under approval number K151589.

What company makes BD MAX CT/GC/TV, BD MAX INSTRUMENT?

BD MAX CT/GC/TV, BD MAX INSTRUMENT is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD MAX CT/GC/TV, BD MAX INSTRUMENT?

The FDA product code for BD MAX CT/GC/TV, BD MAX INSTRUMENT is OUY.

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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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