510(k) K081715

FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM by Taidoc Technology Corporation — Product Code NBW

K081715 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM". The FDA issued a decision of Substantially Equivalent on Dec 17, 2008. 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
Dec 17, 2008
Date Received
Jun 18, 2008
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 K081715. Report a data issue: hello@regdatalab.com.