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FDA 510(k)

BD MAX CDIFF ASSAY, BD MAX INSTRUMENT

K-Number: K130470 · 2013-04-02

ApplicantGeneohm Sciences Canada, Inc. (Bd Diagnostics)
Decision Date2013-04-02
Product CodeOZN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD MAX CDIFF ASSAY, BD MAX INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Diagnostics). It received FDA 510(k) clearance on 2013-04-02 under 510(k) number K130470. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

BD MAX CDIFF ASSAY, BD MAX INSTRUMENT is a medical device that received FDA 510(k) clearance on 2013-04-02. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Diagnostics). The 510(k) number is K130470.

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

BD MAX CDIFF ASSAY, BD MAX INSTRUMENT received FDA 510(k) clearance on 2013-04-02, under 510(k) number K130470.

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

The FDA 510(k) record lists Geneohm Sciences Canada, Inc. (Bd Diagnostics) as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for BD MAX CDIFF ASSAY, BD MAX INSTRUMENT is OZN.

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Other records listing Geneohm Sciences Canada, Inc. (Bd Diagnostics) as applicant

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Related Devices (Code: OZN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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