510(k) K042005

ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222 by Taidoc Technology Corporation — Product Code NBW

K042005 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222". The FDA issued a decision of Substantially Equivalent on Aug 27, 2004. 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
Aug 27, 2004
Date Received
Jul 26, 2004
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 K042005. Report a data issue: hello@regdatalab.com.