The following data is part of a premarket notification filed by Roche Diagnostics Operations Inc with the FDA for Accu-chek Aviva Expert Blood Glucose Monitoring System.
Device ID | K131366 |
510k Number | K131366 |
Device Name: | ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM |
Classification | Glucose Dehydrogenase, Glucose |
Applicant | ROCHE DIAGNOSTICS OPERATIONS INC 9115 HAGUE RD Indianapolis, IN 46250 |
Contact | Nathan Carrington |
Correspondent | Nathan Carrington ROCHE DIAGNOSTICS OPERATIONS INC 9115 HAGUE RD Indianapolis, IN 46250 |
Product Code | LFR |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-13 |
Decision Date | 2013-10-11 |
Summary: | summary |