Device Classification Name |
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device |
510(K) Number |
K182046 |
Device Name |
System, Test, Blood Glucose, Over The Counter |
Applicant |
Tyson Bioresearch, Inc.
5F., No. 16, 18, 20, 22, Kedong 3rd Rd.
Zhunan Township 35053 TW
Other 510(k) Applications for this Company
|
Contact |
Vance Chang
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 |
07/31/2018 |
Decision Date |
11/30/2018 |
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 |
|