• 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 system, test, blood glucose, over the counter
510(k) Number K080853
Device Name DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM
Original Applicant
GENEXEL-SEIN, INC.
845 aronson lake court
roswell,  GA  30075
Original Contact jay mansour
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   DXN   JJX  
Date Received03/26/2008
Decision Date 02/20/2009
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-