Sd Biosensor

FDA Filings

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

FDA Registration(s)

• Registration Number: 3008959428
• FEI Number: 3008959428
• Name: SD BIOSENSOR
• Owner & Operator: SD Biosensor, Inc.
• Contact Address: C-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:
  • Priscilla Chung
  • LK Consulting Group USA, Inc.
  • 714 2025789
  • juhee.c@lkconsultinggroup.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 74, 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

FDA Filings

Device Company	Device	Date
QKP SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD? Q COVID-19 Ag Test	2020-04-13
QKP SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD? Q COVID-19 Ag Control	2020-04-13
QKO SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD? Q COVID-19 IgM/IgG Duo Test	2020-03-21
QKO SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD? COVID-19 IgM/IgG Control	2020-03-21
PMN K160282 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD LipidoCare Professional System	2017-12-04
PMN K160282 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD LipidoCare Home System	2017-12-04
PMN K160282 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD LipidoCare BT Professional System	2017-12-04
PMN K160282 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD LipidoCare BT Home System	2017-12-04
PMN K160282 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	CURO L7 System	2017-12-04
PMN K160282 | LBR SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD LipidoCare Professional System	2017-12-04
PMN K160282 | LBR SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD LipidoCare Home System	2017-12-04
PMN K160282 | LBR SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD LipidoCare BT Professional System	2017-12-04
PMN K160282 | LBR SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD LipidoCare BT Home System	2017-12-04
PMN K160282 | LBR SD BIOSENSOR [SD Biosensor, Inc.]	CURO L7 System	2017-12-04
PMN K160282 | JGY SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD LipidoCare Professional System	2017-12-04
PMN K160282 | JGY SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD LipidoCare Home System	2017-12-04
PMN K160282 | JGY SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD LipidoCare BT Professional System	2017-12-04
PMN K160282 | JGY SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD LipidoCare BT Home System	2017-12-04
PMN K160282 | JGY SD BIOSENSOR [SD Biosensor, Inc.]	CURO L7 System	2017-12-04
PMN K160282 | CHH SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD LipidoCare Professional System	2017-12-04
PMN K160282 | CHH SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD LipidoCare Home System	2017-12-04
PMN K160282 | CHH SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD LipidoCare BT Professional System	2017-12-04
PMN K160282 | CHH SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD LipidoCare BT Home System	2017-12-04
PMN K160282 | CHH SD BIOSENSOR [SD Biosensor, Inc.]	CURO L7 System	2017-12-04
PMN K160282 SD BIOSENSOR	SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System	2017-10-17
PMN K153201 SD BIOSENSOR	SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System	2016-06-24
PMN K151265 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNavii GDH Blood Glucose Monitoring System	2015-11-30
PMN K151265 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNFC Multi Blood Glucose Test Strips	2015-11-30
PMN K151265 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNFC Multi Blood Glucose Monitoring System	2015-11-30
PMN K151265 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNFC Blood Glucose Test Strips	2015-11-30
PMN K151265 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNFC Blood Glucose Monitoring System	2015-11-30
PMN K151265 | LFR SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNavii GDH Blood Glucose Monitoring System	2015-11-30
PMN K151265 | LFR SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNFC Multi Blood Glucose Test Strips	2015-11-30
PMN K151265 | LFR SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNFC Multi Blood Glucose Monitoring System	2015-11-30
PMN K151265 | LFR SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNFC Blood Glucose Test Strips	2015-11-30
PMN K151265 | LFR SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNFC Blood Glucose Monitoring System	2015-11-30
PMN K151265 | JJX SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNavii GDH Blood Glucose Monitoring System	2015-11-30
PMN K151265 | JJX SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNFC Multi Blood Glucose Test Strips	2015-11-30
PMN K151265 | JJX SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNFC Multi Blood Glucose Monitoring System	2015-11-30
PMN K151265 | JJX SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNFC Blood Glucose Test Strips	2015-11-30
PMN K151265 | JJX SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNFC Blood Glucose Monitoring System	2015-11-30
PMN K151265 SD BIOSENSOR	SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System	2015-11-24
PMN K140827 | LCP SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD A1cCare System	2015-10-18
PMN K140827 | LCP SD BIOSENSOR [SD Biosensor, Inc.]	SD HbA1c Control Set	2015-10-18
PMN K140827 | LCP SD BIOSENSOR [SD Biosensor, Inc.]	SD A1cCare Test Kit	2015-10-18
PMN K140827 | JJX SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD A1cCare System	2015-10-18
PMN K140827 | JJX SD BIOSENSOR [SD Biosensor, Inc.]	SD HbA1c Control Set	2015-10-18
PMN K140827 | JJX SD BIOSENSOR [SD Biosensor, Inc.]	SD A1cCare Test Kit	2015-10-18
PMN K140827 | JJE SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD A1cCare System	2015-10-18
PMN K140827 | JJE SD BIOSENSOR [SD Biosensor, Inc.]	SD HbA1c Control Set	2015-10-18
PMN K140827 | JJE SD BIOSENSOR [SD Biosensor, Inc.]	SD A1cCare Test Kit	2015-10-18
PMN K132929 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	GlucoSec Mentor NFC Blood Glucose Test Strips	2015-08-31
PMN K132929 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	GlucoSec Mentor NFC Blood Glucose Monitoring System	2015-08-31
JQP SD BIOSENSOR [SD Biosensor, Inc.]	GlucoNavii? App	2015-02-16
OUG SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD DMS	2015-01-20
PMN K123517 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Mentor Multi Blood Glucose Test Strips	2014-02-04
PMN K123517 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Mentor Multi Blood Glucose Monitoring System	2014-02-04
PMN K123517 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Mentor Blood Glucose Test Strips	2014-02-04
PMN K123517 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Mentor Blood Glucose Monitoring System	2014-02-04
PMN K123517 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Link0.3 Blood Glucose Test Strips	2014-02-04
PMN K123517 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Link0.3 Blood Glucose Monitoring System	2014-02-04
PMN K123517 | JJX SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Mentor Multi Blood Glucose Test Strips	2014-02-04
PMN K123517 | JJX SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Mentor Multi Blood Glucose Monitoring System	2014-02-04
PMN K123517 | JJX SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Mentor Blood Glucose Test Strips	2014-02-04
PMN K123517 | JJX SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Mentor Blood Glucose Monitoring System	2014-02-04
PMN K123517 | JJX SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Link0.3 Blood Glucose Test Strips	2014-02-04
PMN K123517 | JJX SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Link0.3 Blood Glucose Monitoring System	2014-02-04
PMN K123517 | CGA SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Mentor Multi Blood Glucose Test Strips	2014-02-04
PMN K123517 | CGA SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Mentor Multi Blood Glucose Monitoring System	2014-02-04
PMN K123517 | CGA SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Mentor Blood Glucose Test Strips	2014-02-04
PMN K123517 | CGA SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Mentor Blood Glucose Monitoring System	2014-02-04
PMN K123517 | CGA SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Link0.3 Blood Glucose Test Strips	2014-02-04
PMN K123517 | CGA SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD Link0.3 Blood Glucose Monitoring System	2014-02-04
PMN K123517 SD BIOSENSOR	GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM	2014-01-17
PMN K100398 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNavii	2011-03-23
PMN K100398 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM	2011-03-23
PMN K100398 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	SD CodeFree	2011-03-23
PMN K100398 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	Catalogue Number 01GC11 Series	2011-03-23
PMN K100398 | CGA SD BIOSENSOR [SD Biosensor, Inc.]	STANDARD GlucoNavii	2011-03-23
PMN K100398 | CGA SD BIOSENSOR [SD Biosensor, Inc.]	SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM	2011-03-23
PMN K100398 | CGA SD BIOSENSOR [SD Biosensor, Inc.]	SD CodeFree	2011-03-23
PMN K100398 | CGA SD BIOSENSOR [SD Biosensor, Inc.]	Catalogue Number 01GC11 Series	2011-03-23
PMN K082683 | NBW SD BIOSENSOR [SD Biosensor, Inc.]	SD Check Gold	2011-03-23
PMN K082683 | JJX SD BIOSENSOR [SD Biosensor, Inc.]	SD Check Gold	2011-03-23
PMN K082683 | CGA SD BIOSENSOR [SD Biosensor, Inc.]	SD Check Gold	2011-03-23

Similar & Related FDA Registered Companies

• SD Biosensor USA
• SD Biosensor, Inc.