Device Classification Name |
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device |
510(K) Number |
K151265 |
Device Name |
System, Test, Blood Glucose, Over The Counter |
Applicant |
SD BIOSENSOR
C-4TH&5TH, 16, DEOGYEONG-DAERO,
1556BEON-GIL, YEONGTONG-GU
SUWON-SI 363-951 KR
Other 510(k) Applications for this Company
|
Contact |
YEON PARK
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 |
05/13/2015 |
Decision Date |
11/24/2015 |
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 |
|