510(k) K090188

U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222 by Taidoc Technology Corporation — Product Code NBW

K090188 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222". The FDA issued a decision of Substantially Equivalent on Jul 13, 2009. 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
Jul 13, 2009
Date Received
Jan 26, 2009
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)

Source: FDA 510(k) database entry for K090188. Report a data issue: hello@regdatalab.com.