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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name respiratory virus panel nucleic acid assay system
510(K) Number K091667
Model I019A0110, I019C011, I019D0112, I019E0113, S019-0116
Device Name XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116
Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 university ave.
toronto, ontario, 
Contact gloria lee
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OEM   OEP  
Date Received06/09/2009
Decision Date 06/25/2009
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-