510(k) K052818
K052818 is an FDA 510(k) premarket notification submitted by Tyson Bioresearch, Inc. for the device "EZ SMART-168 GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 16, 2006. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Tyson Bioresearch, Inc. has 12 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 16, 2006
- Date Received
- Oct 4, 2005
- 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)