510(k) K132929
K132929 is an FDA 510(k) premarket notification submitted by Sd Biosensor, Inc. for the device "SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 5, 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. Sd Biosensor, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 2015
- Date Received
- September 17, 2013
- 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