Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
510(k) Number K010858
Device Name VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION
Applicant
Id Biomedical Corp.
19204 N. Creek Pkway., Suite 100
Bothell,  WA  98011
Applicant Contact DAVID CLARY
Correspondent
Id Biomedical Corp.
19204 N. Creek Pkway., Suite 100
Bothell,  WA  98011
Correspondent Contact DAVID CLARY
Regulation Number866.1640
Classification Product Code
MYI  
Date Received03/22/2001
Decision Date 05/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-