510(k) K131029
K131029 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations, Inc. for the device "ACCU-CHEK AVIVA PLUS TEST STRIP". The FDA issued a decision of Substantially Equivalent on August 9, 2013. 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 Operations, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 2013
- Date Received
- April 12, 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