Cleared Traditional

VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION

K010858 · Id Biomedical Corp. · Microbiology

May 2001

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K010858 is an FDA 510(k) clearance for the VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION, a System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (Class II — Special Controls, product code MYI), submitted by Id Biomedical Corp. (Bothell, US). The FDA issued a Cleared decision on May 24, 2001, 63 days after receiving the submission on March 22, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K010858 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2001
Decision Date	May 24, 2001
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	MYI — System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1640