• 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 respiratory virus panel nucleic acid assay system
510(k) Number K092500
Device Name MODIFICATION TO PROFLU+ ASSAY
Original Applicant
PRODESSE, INC.
w229n1870 westwood dr.
waukesha,  WI  53186
Original Contact kristine schraufnagel
Regulation Number866.3980
Classification Product Code
OCC  
Date Received08/14/2009
Decision Date 08/20/2009
Decision substantially equivalent (SE)
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
-
-