510(k) K100406
K100406 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "FORA V20 BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 11, 2010. The device falls under product code CGA (Glucose Oxidase, Glucose), 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
- May 11, 2010
- Date Received
- Feb 16, 2010
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Glucose Oxidase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type
- 510(k)