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FDA 510(k)

VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE

K-Number: K020576 · 2002-05-01

ApplicantId Biomedical Corp.
Decision Date2002-05-01
Product CodeNIJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE is the device name listed in this FDA 510(k) record. The listed applicant is Id Biomedical Corp.. It received FDA 510(k) clearance on 2002-05-01 under 510(k) number K020576. 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 VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE?

VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE is a medical device that received FDA 510(k) clearance on 2002-05-01. The listed applicant is Id Biomedical Corp.. The 510(k) number is K020576.

When did VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE receive FDA 510(k) clearance?

VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE received FDA 510(k) clearance on 2002-05-01, under 510(k) number K020576.

Who is the listed applicant for VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE?

The FDA 510(k) record lists Id Biomedical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE?

The FDA product code for VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE is NIJ.

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Other records listing Id Biomedical Corp. 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.

K010858VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTIONK990640VELOGENE RAPID MRSA IDENTIFICATION ASSAY

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 AssayCepheidK061686IDI-VANR ASSAYGeneohm Sciences Canada, Inc.

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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