VELOGENE RAPID MRSA IDENTIFICATION ASSAY— 510(k) K990640

Name: FDA 510(k) clearance K990640
Creator: U.S. Food and Drug Administration
Published: 1999-07-09

Substantially Equivalent

Id Biomedical Corp.

FDA 510(k) clearance K990640 for VELOGENE RAPID MRSA IDENTIFICATION ASSAY, Substantially Equivalent on 1999-07-09. Applicant: Id Biomedical Corp.. Device class: 2.

Clearance details

Applicant: Id Biomedical Corp.
Product code: Code MYI
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 1999-02-26
Decision date: 1999-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnaby, British Columbia, CA

Download summary PDF View on FDA.gov ↗

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