Device Classification Name |
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device |
510(K) Number |
K100437 |
Device Name |
System, Test, Blood Glucose, Over The Counter |
Applicant |
BESTGEN BIOTECH CORP.
7F, NO.186, JIAN 1ST RD.,
JHONGHE CITY, TAIPEI COUNTY 23511 TW
Other 510(k) Applications for this Company
|
Contact |
STEVEN SHEN
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 |
02/17/2010 |
Decision Date |
01/12/2012 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CH - Clinical Chemistry |
Review Advisory Committee |
CH - Clinical Chemistry |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|