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FDA 510(k)

VELOGENE RAPID MRSA IDENTIFICATION ASSAY

K-Number: K990640 · 1999-07-09

ApplicantId Biomedical Corp.
Decision Date1999-07-09
Product CodeMYI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VELOGENE RAPID MRSA IDENTIFICATION ASSAY 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 1999-07-09 under 510(k) number K990640. The device is classified under product code MYI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VELOGENE RAPID MRSA IDENTIFICATION ASSAY?

VELOGENE RAPID MRSA IDENTIFICATION ASSAY is a medical device that received FDA 510(k) clearance on 1999-07-09. The listed applicant is Id Biomedical Corp.. The 510(k) number is K990640.

When did VELOGENE RAPID MRSA IDENTIFICATION ASSAY receive FDA 510(k) clearance?

VELOGENE RAPID MRSA IDENTIFICATION ASSAY received FDA 510(k) clearance on 1999-07-09, under 510(k) number K990640.

Who is the listed applicant for VELOGENE RAPID MRSA IDENTIFICATION ASSAY?

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 RAPID MRSA IDENTIFICATION ASSAY?

The FDA product code for VELOGENE RAPID MRSA IDENTIFICATION ASSAY is MYI.

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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.

K020576VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VREK010858VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION

Related Devices (Code: MYI)

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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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