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FDA 510(k)

BD MAX GBS ASSAY, BD MAX INSTRUMENT

K-Number: K111860 · 2012-02-16

ApplicantBecton, Dickinson & CO
Decision Date2012-02-16
Product CodeNJR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD MAX GBS ASSAY, BD MAX INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson & CO. It received FDA 510(k) clearance on 2012-02-16 under 510(k) number K111860. The device is classified under product code NJR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD MAX GBS ASSAY, BD MAX INSTRUMENT?

BD MAX GBS ASSAY, BD MAX INSTRUMENT is a medical device that received FDA 510(k) clearance on 2012-02-16. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K111860.

When did BD MAX GBS ASSAY, BD MAX INSTRUMENT receive FDA 510(k) clearance?

BD MAX GBS ASSAY, BD MAX INSTRUMENT received FDA 510(k) clearance on 2012-02-16, under 510(k) number K111860.

Who is the listed applicant for BD MAX GBS ASSAY, BD MAX INSTRUMENT?

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

What is the FDA product code for BD MAX GBS ASSAY, BD MAX INSTRUMENT?

The FDA product code for BD MAX GBS ASSAY, BD MAX INSTRUMENT is NJR.

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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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