• 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 K020866
Device Name FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
Original Applicant
ABBOTT DIABETES CARE INC.
1360 south loop rd.
alameda,  CA  94502 7000
Original Contact donna k templeman
Regulation Number862.1345
Classification Product Code
NBW  
Date Received03/18/2002
Decision Date 06/11/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-