510(k) K150396
Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips by
Apex BioTechnology Corp.
— Product Code NBW
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 14, 2015
- Date Received
- February 18, 2015
- 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