VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE— 510(k) K020576

Name: FDA 510(k) clearance K020576
Creator: U.S. Food and Drug Administration
Published: 2002-05-01

Substantially Equivalent

Id Biomedical Corp.

FDA 510(k) clearance K020576 for VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE, Substantially Equivalent on 2002-05-01. Applicant: Id Biomedical Corp.. Device class: 2.

Clearance details

Applicant: Id Biomedical Corp.
Product code: Code NIJ
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2002-02-21
Decision date: 2002-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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