510(k) K080501
K080501 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240". The FDA issued a decision of Substantially Equivalent on Apr 21, 2008. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Taidoc Technology Corporation has 122 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 21, 2008
- Date Received
- Feb 25, 2008
- 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
- 510(k)