Sd Biosensor Inc

FDA Filings

This page includes the latest FDA filings for Sd Biosensor Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3008959428
FEI Number3008959428
NameSD BIOSENSOR
Owner & OperatorSD Biosensor, Inc.
Contact AddressC-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu
Suwon-si KR-41 Gyeonggido 16690 KR
Official Correspondent
  • Hyo-Keun Lee
  • 82-31-3000423-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address74, Osongsaengmyeong 4-ro, Osong-eup Heungdeok-gu
Cheongju-si Chungcheongbugdo, 28161 KR
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



Registration Number3012133212
FEI Number3012133212
NamePriscilla Chung
Owner & OperatorSD Biosensor, Inc.
Contact AddressC-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu
Suwon-si KR-41 Gyeonggido 16690 KR
Official Correspondent
  • Hyo-Keun Lee
  • 82-31-3000423-x
US Agent
Importing Logistics Registration
ImporterO2 LIFECARE, INC.
Address23865 VIA DEL RIO
Yorba Linda, CA 92887 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1150 ROOSEVELT, SUITE 200
Irvine, CA 92620 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
SD Biosensor, Inc.
STANDARD™ LipidoCare Analyzer 2023-04-17
SD Biosensor, Inc.
STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile 2023-03-27
SD Biosensor, Inc.
STANDARD™ LipidoCare Analyzer 2023-03-27
SD Biosensor, Inc.
CURO L7 Analyzer 2020-05-12
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD? Q COVID-19 Ag Test2020-04-13
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD? Q COVID-19 Ag Control2020-04-13
Priscilla Chung [SD Biosensor, Inc.]
STANDARD? Q COVID-19 Ag Test2020-04-13
Priscilla Chung [SD Biosensor, Inc.]
STANDARD? Q COVID-19 Ag Control2020-04-13
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD? Q COVID-19 IgM/IgG Duo Test2020-03-21
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD? COVID-19 IgM/IgG Control2020-03-21
Priscilla Chung [SD Biosensor, Inc.]
STANDARD? Q COVID-19 IgM/IgG Duo Test2020-03-21
Priscilla Chung [SD Biosensor, Inc.]
STANDARD? COVID-19 IgM/IgG Control2020-03-21
SD Biosensor, Inc.
SD GlucoNavii Blood Glucose Test Strip 2018-07-06
SD Biosensor, Inc.
SD GlucoNavii Blood Glucose Test Strip 2018-07-06
SD Biosensor, Inc.
SD Glucose Control Solution 2018-07-06
SD Biosensor, Inc.
SD GlucoNavii Blood Glucose Monitoring System 2018-07-06
SD Biosensor, Inc.
SD GlucoNavii Blood Glucose Monitoring System 2018-07-06
SD Biosensor, Inc.
SD GlucoNavii Blood Glucose Monitoring System 2018-07-06
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD LipidoCare Professional System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD LipidoCare Home System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD LipidoCare BT Professional System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD LipidoCare BT Home System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
CURO L7 System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD LipidoCare Professional System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD LipidoCare Home System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD LipidoCare BT Professional System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD LipidoCare BT Home System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
CURO L7 System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD LipidoCare Professional System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD LipidoCare Home System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD LipidoCare BT Professional System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD LipidoCare BT Home System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
CURO L7 System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD LipidoCare Professional System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD LipidoCare Home System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD LipidoCare BT Professional System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD LipidoCare BT Home System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
CURO L7 System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD LipidoCare Professional System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD LipidoCare Home System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD LipidoCare BT Professional System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD LipidoCare BT Home System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
CURO L7 System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD LipidoCare Professional System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD LipidoCare Home System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD LipidoCare BT Professional System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD LipidoCare BT Home System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
CURO L7 System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD LipidoCare Professional System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD LipidoCare Home System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD LipidoCare BT Professional System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD LipidoCare BT Home System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
CURO L7 System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD LipidoCare Professional System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD LipidoCare Home System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD LipidoCare BT Professional System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD LipidoCare BT Home System2017-12-04
Priscilla Chung [SD Biosensor, Inc.]
CURO L7 System2017-12-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNavii GDH Blood Glucose Monitoring System2015-11-30
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNFC Multi Blood Glucose Test Strips2015-11-30
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNFC Multi Blood Glucose Monitoring System2015-11-30
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNFC Blood Glucose Test Strips2015-11-30
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNFC Blood Glucose Monitoring System2015-11-30
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNavii GDH Blood Glucose Monitoring System2015-11-30
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNFC Multi Blood Glucose Test Strips2015-11-30
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNFC Multi Blood Glucose Monitoring System2015-11-30
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNFC Blood Glucose Test Strips2015-11-30
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNFC Blood Glucose Monitoring System2015-11-30
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNavii GDH Blood Glucose Monitoring System2015-11-30
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNFC Multi Blood Glucose Test Strips2015-11-30
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNFC Multi Blood Glucose Monitoring System2015-11-30
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNFC Blood Glucose Test Strips2015-11-30
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNFC Blood Glucose Monitoring System2015-11-30
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNavii GDH Blood Glucose Monitoring System2015-11-30
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNFC Multi Blood Glucose Test Strips2015-11-30
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNFC Multi Blood Glucose Monitoring System2015-11-30
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNFC Blood Glucose Test Strips2015-11-30
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNFC Blood Glucose Monitoring System2015-11-30
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNavii GDH Blood Glucose Monitoring System2015-11-30
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNFC Multi Blood Glucose Test Strips2015-11-30
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNFC Multi Blood Glucose Monitoring System2015-11-30
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNFC Blood Glucose Test Strips2015-11-30
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNFC Blood Glucose Monitoring System2015-11-30
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNavii GDH Blood Glucose Monitoring System2015-11-30
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNFC Multi Blood Glucose Test Strips2015-11-30
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNFC Multi Blood Glucose Monitoring System2015-11-30
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNFC Blood Glucose Test Strips2015-11-30
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNFC Blood Glucose Monitoring System2015-11-30
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD A1cCare System2015-10-18
SD BIOSENSOR [SD Biosensor, Inc.]
SD HbA1c Control Set2015-10-18
SD BIOSENSOR [SD Biosensor, Inc.]
SD A1cCare Test Kit2015-10-18
Priscilla Chung [SD Biosensor, Inc.]
STANDARD A1cCare System2015-10-18
Priscilla Chung [SD Biosensor, Inc.]
SD HbA1c Control Set2015-10-18
Priscilla Chung [SD Biosensor, Inc.]
SD A1cCare Test Kit2015-10-18
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD A1cCare System2015-10-18
SD BIOSENSOR [SD Biosensor, Inc.]
SD HbA1c Control Set2015-10-18
SD BIOSENSOR [SD Biosensor, Inc.]
SD A1cCare Test Kit2015-10-18
Priscilla Chung [SD Biosensor, Inc.]
STANDARD A1cCare System2015-10-18
Priscilla Chung [SD Biosensor, Inc.]
SD HbA1c Control Set2015-10-18
Priscilla Chung [SD Biosensor, Inc.]
SD A1cCare Test Kit2015-10-18
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD A1cCare System2015-10-18
SD BIOSENSOR [SD Biosensor, Inc.]
SD HbA1c Control Set2015-10-18
SD BIOSENSOR [SD Biosensor, Inc.]
SD A1cCare Test Kit2015-10-18
Priscilla Chung [SD Biosensor, Inc.]
STANDARD A1cCare System2015-10-18
Priscilla Chung [SD Biosensor, Inc.]
SD HbA1c Control Set2015-10-18
Priscilla Chung [SD Biosensor, Inc.]
SD A1cCare Test Kit2015-10-18
SD Biosensor, Inc.
SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set2015-09-30
SD BIOSENSOR [SD Biosensor, Inc.]
GlucoSec Mentor NFC Blood Glucose Test Strips2015-08-31
SD BIOSENSOR [SD Biosensor, Inc.]
GlucoSec Mentor NFC Blood Glucose Monitoring System2015-08-31
Priscilla Chung [SD Biosensor, Inc.]
GlucoSec Mentor NFC Blood Glucose Test Strips2015-08-31
Priscilla Chung [SD Biosensor, Inc.]
GlucoSec Mentor NFC Blood Glucose Monitoring System2015-08-31
SD BIOSENSOR, INC.
SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM2015-08-05
SD BIOSENSOR [SD Biosensor, Inc.]
GlucoNavii? App2015-02-16
Priscilla Chung [SD Biosensor, Inc.]
GlucoNavii? App2015-02-16
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD DMS2015-01-20
Priscilla Chung [SD Biosensor, Inc.]
STANDARD DMS2015-01-20
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Mentor Multi Blood Glucose Test Strips2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Mentor Multi Blood Glucose Monitoring System2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Mentor Blood Glucose Test Strips2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Mentor Blood Glucose Monitoring System2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Link0.3 Blood Glucose Test Strips2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Link0.3 Blood Glucose Monitoring System2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Mentor Multi Blood Glucose Test Strips2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Mentor Multi Blood Glucose Monitoring System2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Mentor Blood Glucose Test Strips2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Mentor Blood Glucose Monitoring System2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Link0.3 Blood Glucose Test Strips2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Link0.3 Blood Glucose Monitoring System2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Mentor Multi Blood Glucose Test Strips2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Mentor Multi Blood Glucose Monitoring System2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Mentor Blood Glucose Test Strips2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Mentor Blood Glucose Monitoring System2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Link0.3 Blood Glucose Test Strips2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Link0.3 Blood Glucose Monitoring System2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Mentor Multi Blood Glucose Test Strips2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Mentor Multi Blood Glucose Monitoring System2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Mentor Blood Glucose Test Strips2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Mentor Blood Glucose Monitoring System2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Link0.3 Blood Glucose Test Strips2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Link0.3 Blood Glucose Monitoring System2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Mentor Multi Blood Glucose Test Strips2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Mentor Multi Blood Glucose Monitoring System2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Mentor Blood Glucose Test Strips2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Mentor Blood Glucose Monitoring System2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Link0.3 Blood Glucose Test Strips2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD Link0.3 Blood Glucose Monitoring System2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Mentor Multi Blood Glucose Test Strips2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Mentor Multi Blood Glucose Monitoring System2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Mentor Blood Glucose Test Strips2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Mentor Blood Glucose Monitoring System2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Link0.3 Blood Glucose Test Strips2014-02-04
Priscilla Chung [SD Biosensor, Inc.]
STANDARD Link0.3 Blood Glucose Monitoring System2014-02-04
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNavii2011-03-23
SD BIOSENSOR [SD Biosensor, Inc.]
SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM2011-03-23
SD BIOSENSOR [SD Biosensor, Inc.]
SD CodeFree2011-03-23
SD BIOSENSOR [SD Biosensor, Inc.]
Catalogue Number 01GC11 Series2011-03-23
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNavii2011-03-23
Priscilla Chung [SD Biosensor, Inc.]
SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM2011-03-23
Priscilla Chung [SD Biosensor, Inc.]
SD CodeFree2011-03-23
Priscilla Chung [SD Biosensor, Inc.]
Catalogue Number 01GC11 Series2011-03-23
SD BIOSENSOR [SD Biosensor, Inc.]
STANDARD GlucoNavii2011-03-23
SD BIOSENSOR [SD Biosensor, Inc.]
SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM2011-03-23
SD BIOSENSOR [SD Biosensor, Inc.]
SD CodeFree2011-03-23
SD BIOSENSOR [SD Biosensor, Inc.]
Catalogue Number 01GC11 Series2011-03-23
Priscilla Chung [SD Biosensor, Inc.]
STANDARD GlucoNavii2011-03-23
Priscilla Chung [SD Biosensor, Inc.]
SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM2011-03-23
Priscilla Chung [SD Biosensor, Inc.]
SD CodeFree2011-03-23
Priscilla Chung [SD Biosensor, Inc.]
Catalogue Number 01GC11 Series2011-03-23
SD BIOSENSOR [SD Biosensor, Inc.]
SD Check Gold2011-03-23
Priscilla Chung [SD Biosensor, Inc.]
SD Check Gold2011-03-23
SD BIOSENSOR [SD Biosensor, Inc.]
SD Check Gold2011-03-23
Priscilla Chung [SD Biosensor, Inc.]
SD Check Gold2011-03-23
SD BIOSENSOR [SD Biosensor, Inc.]
SD Check Gold2011-03-23
Priscilla Chung [SD Biosensor, Inc.]
SD Check Gold2011-03-23

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020020512463Port Bustamante,Jamaica -> San Juan, Puerto RicoSD CODEFREE BLOOD GLUCOSE TEST SYSTEM CI NO : SDPHY191210-1 PI NO : PJJ191118-2 TEL: 82313000400 FAX: 82313604990 FREIGHT PREPAID CARGO IS STOWED IN A REFRIGERATED CONTAINER S AT THE SHIPPER'S REQUESTED CARRYING TEMPERATU107 PCS
2019091969158Port Bustamante,Jamaica -> San Juan, Puerto RicoSD CODEFREE BLOOD GLUCOSE TEST SYSTEM SD CODEFREE BLOOD GLUCOSE 50TEST STRIP SD CODEFREE PLUS BLOOD GLUCOSE MONITORIN CI NO. SDPHY190823-1 FREIGHT PREPAID CARGO IS STOWED IN A REFRIGERATED CONTAINER S AT THE SHIPPER'S REQUESTED CARRYING TEMPERATU146 PCS
2019061363909Pusan,South Korea -> Los Angeles, CaliforniaSD GLUCONAVII SOLO METER277 CTN
2019040856098Pusan,South Korea -> Los Angeles, CaliforniaSD GLUCONAVII SOLO METER299 CTN
2019030832677Pusan,South Korea -> Los Angeles, CaliforniaSD GLUCONAVII SOLO METER278 PKG
2018101567072Pusan,South Korea -> Los Angeles, CaliforniaSD GLUCONAVII SOLO METER253 CTN
2018071265403Pusan,South Korea -> Long Beach, CaliforniaSD GLUCONAVII SOLO METER120 CTN
2018051943074Pusan,South Korea -> Long Beach, CaliforniaSD GLUCONAVII SOLO METER144 CTN

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.