FDA 510(k) Application Details - K073494

Device Classification Name System, Test, Blood Glucose, Over The Counter

  More FDA Info for this Device
510(K) Number K073494
Device Name System, Test, Blood Glucose, Over The Counter
Applicant TaiDoc Technology Corporation
6F, NO. 127, WUGONG 2ND RD
WUGU TOWNSHIP
TAIPEI COUNTY 248 TW
Other 510(k) Applications for this Company
Contact Yuhua Chen
Other 510(k) Applications for this Contact
Regulation Number 862.1345

  More FDA Info for this Regulation Number
Classification Product Code NBW
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 12/12/2007
Decision Date 04/02/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact