510(k) K173511

ActiveCare TD-4121 Blood Glucose Monitoring System by Taidoc Technology Corporation — Product Code NBW

K173511 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "ActiveCare TD-4121 Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on July 12, 2018. 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
July 12, 2018
Date Received
November 13, 2017
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