510(k) K181527
K181527 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on October 3, 2018. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2018
- Date Received
- June 11, 2018
- 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