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510(k) K010858

Device
VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION
Applicant
ID BIOMEDICAL CORP.
510(k) number
K010858
Product code
MYI  
Decision
Substantially Equivalent (SESE)
Decision date
2001-05-24
Date received
2001-03-22
Regulation
866.1640
Classification name
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID CLARY
Address
19204 N. Creek Pkway., Suite 100 Bothell WA US 98011 98011

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MYI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140619MECA XPRESSFISHAdvandx, Inc.2014-10-10
K133851ALERE PBP2A SA/CONS CULTURE COLONY TESTAlere Scarborough, Inc.2014-09-03
K121905ALERE PBP2A TESTAlere Scarborough, Inc.2012-07-26
K090301BINAXNOW PBP2A TEST, MODEL 890-000Binax, Inc.2010-04-14
K091766CLEARVIEW EXACT PBP2A TEST, MODEL 891-000Binax, Inc.2010-02-24
K062864MASTALEX -MRSA, MODEL RST501Mast Group , Ltd.2006-10-18
K011710OXOID PBP2 1 LATEX AGGLUTINATION TESTOxoid , Ltd.2002-04-02
K011400MRSA-SCREENDenka Seiken'S2002-03-27
K990640VELOGENE RAPID MRSA IDENTIFICATION ASSAYId Biomedical Corp.1999-07-09

Legacy Summary#

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FDA Review#

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