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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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 K131366
Device Name ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
Applicant
ROCHE DIAGNOSTICS OPERATIONS INC
9115 HAGUE RD
INDIANAPOLIS,  IN  46250
Applicant Contact NATHAN CARRINGTON
Correspondent
ROCHE DIAGNOSTICS OPERATIONS INC
9115 HAGUE RD
INDIANAPOLIS,  IN  46250
Correspondent Contact NATHAN CARRINGTON
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Code
NDC  
Date Received05/13/2013
Decision Date 10/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-