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FDA 510(k)

IDI-VANR ASSAY

K-Number: K061686 · 2006-08-30

ApplicantGeneohm Sciences Canada, Inc.
Decision Date2006-08-30
Product CodeNIJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IDI-VANR ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Geneohm Sciences Canada, Inc.. It received FDA 510(k) clearance on 2006-08-30 under 510(k) number K061686. 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 IDI-VANR ASSAY?

IDI-VANR ASSAY is a medical device that received FDA 510(k) clearance on 2006-08-30. The listed applicant is Geneohm Sciences Canada, Inc.. The 510(k) number is K061686.

When did IDI-VANR ASSAY receive FDA 510(k) clearance?

IDI-VANR ASSAY received FDA 510(k) clearance on 2006-08-30, under 510(k) number K061686.

Who is the listed applicant for IDI-VANR ASSAY?

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

What is the FDA product code for IDI-VANR ASSAY?

The FDA product code for IDI-VANR ASSAY is NIJ.

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Other records listing Geneohm Sciences Canada, Inc. as applicant

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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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.K102416BD GENEOHM VANR ASSAYBd Diagnostics ScienceK092953Xpert VanA AssayCepheidK020576VELOGENE 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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