510(k) K092902

U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC by Taidoc Technology Corporation — Product Code NBW

K092902 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC". The FDA issued a decision of Substantially Equivalent on Mar 2, 2010. 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
Mar 2, 2010
Date Received
Sep 21, 2009
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)

Source: FDA 510(k) database entry for K092902. Report a data issue: hello@regdatalab.com.