Device Classification Name |
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device |
510(K) Number |
K083099 |
Device Name |
System, Test, Blood Glucose, Over The Counter |
Applicant |
EPS BIO TECHNOLOGY CORP.
2 F,NO. 49-2, LANE 2, SEC. 2,
GUANG FU ROAD
HSINCHU CITY 30071 TW
Other 510(k) Applications for this Company
|
Contact |
Y. C LEI
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 |
10/20/2008 |
Decision Date |
01/16/2009 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CH - Clinical Chemistry |
Review Advisory Committee |
CH - Clinical Chemistry |
Statement / Summary / Purged Status |
Statement |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|