510(k) K101631

FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM by Taidoc Technology Corporation — Product Code NBW

K101631 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on Sep 2, 2011. 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
Sep 2, 2011
Date Received
Jun 10, 2010
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 K101631. Report a data issue: hello@regdatalab.com.