Device Classification Name |
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device |
510(K) Number |
K170079 |
Device Name |
System, Test, Blood Glucose, Over The Counter |
Applicant |
TYSON BIORESEARCH, INC.
5F, NO. 22, KE E. ROAD III
SCIENCE-BASED INDUSTRIAL PARK
CHU-NAN, MIAO-LI COUNTY 350 TW
Other 510(k) Applications for this Company
|
Contact |
WEN-HAI TSAI
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 |
01/10/2017 |
Decision Date |
10/06/2017 |
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 |
|