510(k) K100405

FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM by Taidoc Technology Corporation — Product Code CGA

K100405 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on Jul 9, 2010. The device falls under product code CGA (Glucose Oxidase, Glucose), 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 9, 2010
Date Received
Feb 16, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type
510(k)

Source: FDA 510(k) database entry for K100405. Report a data issue: hello@regdatalab.com.