Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name glucose dehydrogenase, glucose
510(K) Number K121190
Model 7377
Device Name CONTOUR NEXT BLOOD GLUCOSE METER
Applicant
BAYER HEALTHCARE LLC
555 white plains rd.
tarrytown,  NY  10591
Contact charles ryan
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Codes
JJX   NBW  
Date Received04/19/2012
Decision Date 07/26/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Clinical Trials NCT01474317
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-