Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1805225952
Device Listing 1805225952
Listing Summary
#
Listing key
1805225952
Premarket submission
K113636
Device
BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
Applicant
Philosys Co., Ltd.
Product code
CGA
Decision date
2013-03-08
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
156082
3010172486
3010172486
Priscilla Chung
1
N
2020-04-25
1150 ROOSEVELT, SUITE 200 Irvine CA US 92620
221470
3014848701
3014848701
PHILOSYS Co., Ltd.
1
N
2020-04-25
#3, 23, Jeongjail-ro, Bundang-gu Seongnam-si Gyeonggido KR 13486
233782
3015949778
3015949778
Priscilla Chung
1
N
2020-04-25
1150 ROOSEVELT, SUITE 200 Irvine CA US 92620