The following data is part of a premarket notification filed by Roche Diagnostics Operations Inc with the FDA for Accu-chek Aviva Plus Test Strip.
Device ID | K131029 |
510k Number | K131029 |
Device Name: | ACCU-CHEK AVIVA PLUS TEST STRIP |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | ROCHE DIAGNOSTICS OPERATIONS INC 9115 HAGUE RD Indianapolis, IN 46250 |
Contact | Khone Saysana |
Correspondent | Khone Saysana ROCHE DIAGNOSTICS OPERATIONS INC 9115 HAGUE RD Indianapolis, IN 46250 |
Product Code | NBW |
Subsequent Product Code | LFR |
Subsequent Product Code | LZG |
Subsequent Product Code | NDC |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-04-12 |
Decision Date | 2013-08-09 |
Summary: | summary |