Accu-Chek Aviva Connect Blood Glucose Monitoring System
FDA 510(k) K141867 · Roche Diagnostics
510(k) numberK141867
Submission
- Device name
- Accu-Chek Aviva Connect Blood Glucose Monitoring System
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- July 10, 2014
- Decision date
- March 3, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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Questions and answers
When was Accu-Chek Aviva Connect Blood Glucose Monitoring System cleared by the FDA?
Accu-Chek Aviva Connect Blood Glucose Monitoring System (K141867) received a 510(k) decision of Substantially Equivalent on March 3, 2015, 236 days after the submission was received.
What is the product code of K141867?
The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.