510(k) K151611
K151611 is an FDA 510(k) premarket notification submitted by Lifescan Europe for the device "OneTouch Ultra Plus Flex Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on Dec 14, 2015. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Lifescan Europe has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 14, 2015
- Date Received
- Jun 15, 2015
- Clearance Type
- Traditional
- 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
- 510(k)