Jeonghan Ha

FDA Filings

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

FDA Registration(s)

• Registration Number: 3007382160
• FEI Number: 3007382160
• Name: Jeonghan Ha
• Owner & Operator: i-SENS, Inc.
• Contact Address: 43, Banpo-daero 28-gil, Seocho-gu ; Seoul KR-11 Seoul Teugbyeolsi 06646 KR
• Official Correspondent:
  • Hyun Joon Oh
  • 82-2-9166191-x
• US Agent:
  • Jeonghan Ha
  • i-SENS USA, Inc.
  • 310 3200254
  • 310 3200251
  • i-sens-usa@i-sens.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2461 W. 205th St., Unit B102 ; Torrance, CA 90501 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K192859 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens S Clear BT Blood Glucose Monitoring System	2020-01-25
PMN K193590 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens S Fit BT Blood Glucose Monitoring System	2020-01-19
PMN K192220 | NBW Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier Classic Blood Glucose Monitoring System	2019-12-15
PMN K181273 | NBW Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine Express Blood Glucose Monitoring System	2018-11-01
PMN K181273 | NBW Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine Connex Blood Glucose Monitoring System	2018-11-01
PMN K180866 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens S Fit Blood Glucose Monitoring System	2018-09-02
PMN K170463 | JIN Jeonghan Ha [i-SENS, Inc.]	KetoSens Multi Blood ?-Ketone Monitoring System	2018-04-15
PMN K170463 | JIN Jeonghan Ha [i-SENS, Inc.]	KetoSens Blood ?-Ketone Monitoring System	2018-04-15
PMN K171480 | NBW Jeonghan Ha [i-SENS, Inc.]	VeraSens Blood Glucose Monitoring System	2017-12-13
PMN K171480 | NBW Jeonghan Ha [i-SENS, Inc.]	NoCoding1 Plus Blood Glucose Monitoring System	2017-12-13
PMN K171480 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens N Plus BT Blood Glucose Monitoring System	2017-12-13
PMN K170614 | NBW Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier BLU Blood Glucose Monitoring System	2017-10-26
PMN K170614 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System	2017-10-26
PMN K160742 | NBW Jeonghan Ha [i-SENS, Inc.]	VeraSens Blood Glucose Monitoring System	2017-02-02
PMN K160742 | JJX Jeonghan Ha [i-SENS, Inc.]	VeraSens Blood Glucose Monitoring System	2017-02-02
PMN K160742 | CGA Jeonghan Ha [i-SENS, Inc.]	VeraSens Blood Glucose Monitoring System	2017-02-02
PMN K161834 | NBW Jeonghan Ha [i-SENS, Inc.]	One Drop Blood Glucose Test Strip	2016-12-23
PMN K161834 | CGA Jeonghan Ha [i-SENS, Inc.]	One Drop Blood Glucose Test Strip	2016-12-23
PMN K151164 | NBW Jeonghan Ha [i-SENS, Inc.]	Assure Prism multi Blood Glucose Monitoring System	2015-11-02
PMN K121654 | NBW Jeonghan Ha [i-SENS, Inc.]	SugaChek Blood Glucose Monitoring System	2013-12-04
PMN K121654 | JJX Jeonghan Ha [i-SENS, Inc.]	SugaChek Blood Glucose Monitoring System	2013-12-04
PMN K121654 | CGA Jeonghan Ha [i-SENS, Inc.]	SugaChek Blood Glucose Monitoring System	2013-12-04
PMN K132288 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens N Voice Multi Blood Glucose Monitoring System	2013-12-02
PMN K132288 | JJX Jeonghan Ha [i-SENS, Inc.]	CareSens N Voice Multi Blood Glucose Monitoring System	2013-12-02
PMN K132288 | CGA Jeonghan Ha [i-SENS, Inc.]	CareSens N Voice Multi Blood Glucose Monitoring System	2013-12-02
PMN K131419 | NBW Jeonghan Ha [i-SENS, Inc.]	ACURA PLUS Multi Blood Glucose Monitoring System	2013-12-02
PMN K131419 | CGA Jeonghan Ha [i-SENS, Inc.]	ACURA PLUS Multi Blood Glucose Monitoring System	2013-12-02
FMK Jeonghan Ha [i-SENS, Inc.]	CareSens Sterile Lancets 30G	2013-09-03
FMK Jeonghan Ha [i-SENS, Inc.]	CareSens Sterile Lancets 28G	2013-09-03
FMK Jeonghan Ha [i-SENS, Inc.]	CareLance Lancing Device	2013-09-03
PMN K121133 | NBW Jeonghan Ha [i-SENS, Inc.]	VeraSens Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | NBW Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | NBW Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier Classic Blood Glucose Monitoring System	2012-07-18
PMN K121133 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens N Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | JJX Jeonghan Ha [i-SENS, Inc.]	VeraSens Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | JJX Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | JJX Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier Classic Blood Glucose Monitoring System	2012-07-18
PMN K121133 | JJX Jeonghan Ha [i-SENS, Inc.]	CareSens N Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | CGA Jeonghan Ha [i-SENS, Inc.]	VeraSens Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | CGA Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | CGA Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier Classic Blood Glucose Monitoring System	2012-07-18
PMN K121133 | CGA Jeonghan Ha [i-SENS, Inc.]	CareSens N Voice Blood Glucose Monitoring System	2012-07-18
PMN K120759 | NBW Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier COMPACT Blood Glucose Monitoring System	2012-07-18
PMN K120759 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens N Mini Blood Glucose Monitoring System	2012-07-18
PMN K120759 | JJX Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier COMPACT Blood Glucose Monitoring System	2012-07-18
PMN K120759 | JJX Jeonghan Ha [i-SENS, Inc.]	CareSens N Mini Blood Glucose Monitoring System	2012-07-18
PMN K120759 | CGA Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier COMPACT Blood Glucose Monitoring System	2012-07-18
PMN K120759 | CGA Jeonghan Ha [i-SENS, Inc.]	CareSens N Mini Blood Glucose Monitoring System	2012-07-18
PMN K120351 | NBW Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine Blood Glucose Monitoting System	2012-07-18
PMN K120351 | NBW Jeonghan Ha [i-SENS, Inc.]	Fifty 50 Blood Glucose Monitoring System 2.0 Sport	2012-07-18
PMN K120351 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens N POP Blood Glucose Monitoring System	2012-07-18
PMN K120351 | CGA Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine Blood Glucose Monitoting System	2012-07-18
PMN K120351 | CGA Jeonghan Ha [i-SENS, Inc.]	Fifty 50 Blood Glucose Monitoring System 2.0 Sport	2012-07-18
PMN K120351 | CGA Jeonghan Ha [i-SENS, Inc.]	CareSens N POP Blood Glucose Monitoring System	2012-07-18
PMN K103396 | NBW Jeonghan Ha [i-SENS, Inc.]	COOL Blood Glucose Monitoring System	2012-07-18
PMN K103396 | JJX Jeonghan Ha [i-SENS, Inc.]	COOL Blood Glucose Monitoring System	2012-07-18
PMN K103396 | CGA Jeonghan Ha [i-SENS, Inc.]	COOL Blood Glucose Monitoring System	2012-07-18
PMN K103278 | NBW Jeonghan Ha [i-SENS, Inc.]	Assure Prism Control Solution	2012-07-18
PMN K103278 | JJX Jeonghan Ha [i-SENS, Inc.]	Assure Prism Control Solution	2012-07-18
PMN K103278 | CGA Jeonghan Ha [i-SENS, Inc.]	Assure Prism Control Solution	2012-07-18
PMN K100937 | NBW Jeonghan Ha [i-SENS, Inc.]	PC care Blood Glucose Data Management Software	2012-07-18
PMN K100937 | JQP Jeonghan Ha [i-SENS, Inc.]	PC care Blood Glucose Data Management Software	2012-07-18
PMN K083468 | NBW Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine XL Blood Glucose Monitoring System	2009-04-08
PMN K083468 | NBW Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine Control Solution	2009-04-08
PMN K083468 | NBW Jeonghan Ha [i-SENS, Inc.]	Fifty 50 Blood Glucose Monitoring System 2.0	2009-04-08
PMN K083468 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens N Blood Glucose Monitoring System	2009-04-08
PMN K083468 | JJX Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine XL Blood Glucose Monitoring System	2009-04-08
PMN K083468 | JJX Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine Control Solution	2009-04-08
PMN K083468 | JJX Jeonghan Ha [i-SENS, Inc.]	Fifty 50 Blood Glucose Monitoring System 2.0	2009-04-08
PMN K083468 | JJX Jeonghan Ha [i-SENS, Inc.]	CareSens N Blood Glucose Monitoring System	2009-04-08
PMN K083468 | CGA Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine XL Blood Glucose Monitoring System	2009-04-08
PMN K083468 | CGA Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine Control Solution	2009-04-08
PMN K083468 | CGA Jeonghan Ha [i-SENS, Inc.]	Fifty 50 Blood Glucose Monitoring System 2.0	2009-04-08
PMN K083468 | CGA Jeonghan Ha [i-SENS, Inc.]	CareSens N Blood Glucose Monitoring System	2009-04-08
PMN K080923 | NBW Jeonghan Ha [i-SENS, Inc.]	SmileCheker Blood Glucose Monitoring System	2009-04-08
PMN K080923 | JJX Jeonghan Ha [i-SENS, Inc.]	SmileCheker Blood Glucose Monitoring System	2009-04-08
PMN K080923 | CGA Jeonghan Ha [i-SENS, Inc.]	SmileCheker Blood Glucose Monitoring System	2009-04-08
PMN K052762 | NBW Jeonghan Ha [i-SENS, Inc.]	LIBERTY TEST STRIPS	2006-03-03
PMN K052762 | JJX Jeonghan Ha [i-SENS, Inc.]	LIBERTY TEST STRIPS	2006-03-03
PMN K052762 | CGA Jeonghan Ha [i-SENS, Inc.]	LIBERTY TEST STRIPS	2006-03-03

Similar & Related FDA Registered Companies

• i-SENS USA, Inc.