Device Classification Name |
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device |
510(K) Number |
K153201 |
Device Name |
System, Test, Blood Glucose, Over The Counter |
Applicant |
SD BIOSENSOR
C-4th & 5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu
Suwon-si 443-813 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 |
11/04/2015 |
Decision Date |
06/24/2016 |
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 |
|