510(k) K143467

FORA GD43 Blood Glucose Monitoring System by Taidoc Technology Corporation — Product Code NBW

K143467 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "FORA GD43 Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on May 7, 2015. 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2015
Date Received
December 4, 2014
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