510(k) K133862
K133862 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corporation for the device "ACCU-CHEK AVIVA PLUS SYSTEM". The FDA issued a decision of Substantially Equivalent on April 29, 2014. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Roche Diagnostics Corporation has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2014
- Date Received
- December 19, 2013
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Blood Glucose, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type