• 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 K031843
Device Name MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
MEDLINE INDUSTRIES, INC.
one medline pl.
mundelein,  IL  60060 4486
Original Contact andrea haferkamp
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received06/16/2003
Decision Date 07/03/2003
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-