• 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 | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification
510(k) Number K130551
Device Name CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
Original Applicant
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 clifton rd., n.e.
mailstop c-18
atlanta,  GA  30333
Original Contact hye-joo kim, pharm. d.
Regulation Number866.3332
Classification Product Code
OQW  
Subsequent Product Codes
NSU   NXD   OEP  
Date Received03/04/2013
Decision Date 05/22/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-