510(k) K120042
K120042 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 22, 2012. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. Taidoc Technology Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2012
- Date Received
- January 5, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Glucose Dehydrogenase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type