510(k) K083664

FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245 by Taidoc Technology Corporation — Product Code CGA

K083664 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245". The FDA issued a decision of Substantially Equivalent on Jan 9, 2009. 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
Jan 9, 2009
Date Received
Dec 10, 2008
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 K083664. Report a data issue: hello@regdatalab.com.