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FDA 510(k)

BD GENEOHM VANR ASSAY

K-Number: K102416 · 2011-10-20

ApplicantBd Diagnostics Science
Decision Date2011-10-20
Product CodeNIJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD GENEOHM VANR ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bd Diagnostics Science. It received FDA 510(k) clearance on 2011-10-20 under 510(k) number K102416. The device is classified under product code NIJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD GENEOHM VANR ASSAY?

BD GENEOHM VANR ASSAY is a medical device that received FDA 510(k) clearance on 2011-10-20. The listed applicant is Bd Diagnostics Science. The 510(k) number is K102416.

When did BD GENEOHM VANR ASSAY receive FDA 510(k) clearance?

BD GENEOHM VANR ASSAY received FDA 510(k) clearance on 2011-10-20, under 510(k) number K102416.

Who is the listed applicant for BD GENEOHM VANR ASSAY?

The FDA 510(k) record lists Bd Diagnostics Science as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD GENEOHM VANR ASSAY?

The FDA product code for BD GENEOHM VANR ASSAY is NIJ.

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Related Devices (Code: NIJ)

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.

K243405Xpert vanACepheid®K123753IMDX VANR FOR ABBOTT M2000Intelligent Medical Devices, Inc.K092953Xpert VanA AssayCepheidK061686IDI-VANR ASSAYGeneohm Sciences Canada, Inc.K020576VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VREId Biomedical Corp.

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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