Lifescan Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 3009698388
• FEI Number: 2939301
• Name: Lifescan, Inc.
• Owner & Operator: LIFESCAN, INC.
• Contact Address: 20 Valley Stream Parkway --; Malvern PA 19355 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 20 Valley Stream Parkway ; Malvern, PA 19355 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 20353885013004 LIFESCAN, INC.	OneTouch Ultra	2025-06-30
GUDID 20353885012656 LIFESCAN, INC.	OneTouch Ultra Blue Test Strips 024-273	2022-08-05
PMN K151611 | NBW Lifescan, Inc.	OneTouch Verio Control Solution	2017-05-01
PMN K151611 | NBW Lifescan, Inc.	OneTouch Ultra Plus Test Strips	2017-05-01
PMN K151611 | NBW Lifescan, Inc.	OneTouch Ultra Plus Flex Meter	2017-05-01
PMN K151611 | NBW Lifescan, Inc.	OneTouch Ultra Plus Flex Blood Glucose Monitoring System	2017-05-01
PMN K151611 | LFR Lifescan, Inc.	OneTouch Verio Control Solution	2017-05-01
PMN K151611 | LFR Lifescan, Inc.	OneTouch Ultra Plus Test Strips	2017-05-01
PMN K151611 | LFR Lifescan, Inc.	OneTouch Ultra Plus Flex Meter	2017-05-01
PMN K151611 | LFR Lifescan, Inc.	OneTouch Ultra Plus Flex Blood Glucose Monitoring System	2017-05-01
PMN K150214 | NBW Lifescan, Inc.	OneTouch Verio Test Strips	2017-05-01
PMN K150214 | NBW Lifescan, Inc.	OneTouch Verio Flex Meter	2017-05-01
PMN K150214 | NBW Lifescan, Inc.	OneTouch Verio Flex Blood Glucose Monitoring System	2017-05-01
PMN K150214 | NBW Lifescan, Inc.	OneTouch Verio Control Solution	2017-05-01
PMN K150214 | LFR Lifescan, Inc.	OneTouch Verio Test Strips	2017-05-01
PMN K150214 | LFR Lifescan, Inc.	OneTouch Verio Flex Meter	2017-05-01
PMN K150214 | LFR Lifescan, Inc.	OneTouch Verio Flex Blood Glucose Monitoring System	2017-05-01
PMN K150214 | LFR Lifescan, Inc.	OneTouch Verio Control Solution	2017-05-01
PMN K132618 | NBW Lifescan, Inc.	OneTouch Reveal Web Diabetes Management Application	2017-05-01
PMN K132618 | MRZ Lifescan, Inc.	OneTouch Reveal Web Diabetes Management Application	2017-05-01
PMN K132618 LIFESCAN, INC.	ONETOUCH REVEAL	2013-12-16
PMN K131363 | NBW Lifescan, Inc.	OneTouch Verio Test Strips	2013-09-18
PMN K131363 | NBW Lifescan, Inc.	OneTouch Verio Meter	2013-09-18
PMN K131363 | NBW Lifescan, Inc.	OneTouch Verio Control Solution	2013-09-18
PMN K131363 | NBW Lifescan, Inc.	OneTouch Verio Blood Glucose Monitoring System	2013-09-18
PMN K131363 | LFR Lifescan, Inc.	OneTouch Verio Test Strips	2013-09-18
PMN K131363 | LFR Lifescan, Inc.	OneTouch Verio Meter	2013-09-18
PMN K131363 | LFR Lifescan, Inc.	OneTouch Verio Control Solution	2013-09-18
PMN K131363 | LFR Lifescan, Inc.	OneTouch Verio Blood Glucose Monitoring System	2013-09-18
PMN K120558 | NBW Lifescan, Inc.	OneTouch Reveal Mobile Diabetes Management Application	2013-02-11
PMN K120558 | JQP Lifescan, Inc.	OneTouch Reveal Mobile Diabetes Management Application	2013-02-11
PMN K120558 LIFESCAN, INC.	ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION	2013-02-07
PMN K110637 | NBW Lifescan, Inc.	OneTouch Verio Test Strip	2012-04-16
PMN K110637 | NBW Lifescan, Inc.	OneTouch Verio IQ Blood Glucose Monitoring System	2012-04-16
PMN K110637 | NBW Lifescan, Inc.	OneTouch Verio IQ Blood Glucose Meter	2012-04-16
PMN K110637 | NBW Lifescan, Inc.	OneTouch Verio Control Solution	2012-04-16
PMN K110637 | LFR Lifescan, Inc.	OneTouch Verio Test Strip	2012-04-16
PMN K110637 | LFR Lifescan, Inc.	OneTouch Verio IQ Blood Glucose Monitoring System	2012-04-16
PMN K110637 | LFR Lifescan, Inc.	OneTouch Verio IQ Blood Glucose Meter	2012-04-16
PMN K110637 | LFR Lifescan, Inc.	OneTouch Verio Control Solution	2012-04-16
PMN K103553 | JJX Lifescan, Inc.	OneTouch Ultra Control Solutions	2011-03-31
PMN K103553 | JJX Lifescan, Inc.	OneTouch Select Control Solutions	2011-03-31
PMN K093745 LIFESCAN, INC.	ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM	2011-02-11
PMN K082590 | LZG Lifescan, Inc.	OneTouch Ping Meter Remote	2009-01-08
PMN K082590 | CGA Lifescan, Inc.	OneTouch Ping Meter Remote	2009-01-08
PMN K082590 LIFESCAN, INC.	SYMPHONY METER REMOTE	2008-12-17
PMN K082513 LIFESCAN, INC.	ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM	2008-10-22
PMN K081318 | NBW Lifescan, Inc.	OneTouch Zoom Diabetes Management Program	2008-06-26
PMN K081318 | JQP Lifescan, Inc.	OneTouch Zoom Diabetes Management Program	2008-06-26
PMN K081318 LIFESCAN, INC.	ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM	2008-06-09
PMN K073231 LIFESCAN, INC.	ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM	2008-04-18
PMN K984527 | CGA Lifescan, Inc.	OneTouch Zoom Pro Diabetes Management Program	2007-11-05
PMN K072543 | NBW Lifescan, Inc.	OneTouch Select Test Strips	2007-11-05
PMN K072543 | NBW Lifescan, Inc.	OneTouch Select Blood Glucose Monitoring System	2007-11-05
PMN K072543 | NBW Lifescan, Inc.	OneTouch Select Blood Glucose Meter	2007-11-05
PMN K072543 | CGA Lifescan, Inc.	OneTouch Select Test Strips	2007-11-05
PMN K072543 | CGA Lifescan, Inc.	OneTouch Select Blood Glucose Monitoring System	2007-11-05
PMN K072543 | CGA Lifescan, Inc.	OneTouch Select Blood Glucose Meter	2007-11-05
PMN K061118 | NBW Lifescan, Inc.	OneTouch UltraMini Meter	2007-11-05
PMN K061118 | NBW Lifescan, Inc.	OneTouch UltraMini Blood Glucose Monitoring System	2007-11-05
PMN K061118 | NBW Lifescan, Inc.	OneTouch Ultra Blue Test Strips	2007-11-05
PMN K053529 | NBW Lifescan, Inc.	OneTouch Ultra Blue Test Strips	2007-11-05
PMN K053529 | NBW Lifescan, Inc.	OneTouch Ultra 2 Meter	2007-11-05
PMN K053529 | NBW Lifescan, Inc.	OneTouch Ultra 2 Blood Glucose Monitoring System	2007-11-05
PMN K053529 | CGA Lifescan, Inc.	OneTouch Ultra Blue Test Strips	2007-11-05
PMN K053529 | CGA Lifescan, Inc.	OneTouch Ultra 2 Meter	2007-11-05
PMN K053529 | CGA Lifescan, Inc.	OneTouch Ultra 2 Blood Glucose Monitoring System	2007-11-05
PMN K072543 LIFESCAN, INC.	ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM	2007-10-05
PMN K043197 | NBW Lifescan, Inc.	OneTouch Ultra Blue Test Strips	2007-08-20
PMN K043197 | CGA Lifescan, Inc.	OneTouch Ultra Blue Test Strips	2007-08-20
PMN K062195 LIFESCAN, INC.	MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM	2006-08-16
PMN K061118 LIFESCAN, INC.	ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM	2006-05-19
PMN K053529 LIFESCAN, INC.	ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM	2006-01-17
PMN K043197 LIFESCAN, INC.	ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM	2005-05-20
PMN K031472 LIFESCAN, INC.	ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS	2003-08-05
PMN K024194 LIFESCAN, INC.	ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS	2003-02-07
PMN K023194 LIFESCAN, INC.	SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM	2002-10-24
PMN K022922 LIFESCAN, INC.	HARMONY INR MONITORING SYSTEM	2002-09-30
PMN K022724 LIFESCAN, INC.	SURESTEP BLOOD GLUCOSE MONITORING SYSTEM	2002-09-12
PMN K021819 LIFESCAN, INC.	ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM	2002-08-23
PMN K021943 LIFESCAN, INC.	ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM	2002-06-28
PMN K001699 LIFESCAN, INC.	RUBICON PROTHROMBIN TIME MONITORING SYSTEM	2001-05-15
PMN K001441 LIFESCAN, INC.	SATURN BLOOD GLUCOSE MONITORING TEST STRIP	2000-12-18
PMN K984261 LIFESCAN, INC.	SURESTEP BLOOD GLUCOSE MONITORING SYSTEM	1999-05-21
PMN K984527 LIFESCAN, INC.	IN TOUCH DIABETES MANAGEMENT SOFTWARE	1999-04-29
PMN K974451 LIFESCAN, INC.	ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM	1998-01-26
PMN K972473 LIFESCAN, INC.	ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK	1997-12-16
PMN K970556 LIFESCAN, INC.	SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM	1997-05-12
PMN K971014 LIFESCAN, INC.	LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS	1997-04-23
PMN K950816 LIFESCAN, INC.	ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM	1995-07-03
PMN K950727 LIFESCAN, INC.	ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM	1995-06-01
PMN K942455 LIFESCAN, INC.	LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM	1995-03-24
FMK Lifescan, Inc.	OneTouch UltraSoft Lancing Device and Lancets	1994-01-27
FMK Lifescan, Inc.	OneTouch SureSoft	1994-01-27
FMK Lifescan, Inc.	OneTouch Lancing Device	1994-01-27
FMK Lifescan, Inc.	OneTouch FinePoint Lancets	1994-01-27
FMK Lifescan, Inc.	OneTouch Delica Lancing Device and Lancets	1994-01-27
PMN K923544 LIFESCAN, INC.	ONE TOUCH TEST STRIPS	1992-12-03
PMN K922888 LIFESCAN, INC.	ONE TOUCH IIB BLOOD GLUCOSE METER	1992-09-15
PMN K913357 LIFESCAN, INC.	ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST	1991-11-07
PMN K895911 LIFESCAN, INC.	ONE TOUCH II METER	1989-11-08
PMN K894804 LIFESCAN, INC.	SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)	1989-09-28
PMN K864322 LIFESCAN, INC.	MPX SYSTEM, GLUCOSE TEST SYSTEM	1987-02-25
PMN K822699 LIFESCAN, INC.	GLUCOSCAN METER MODEL II	1982-11-05
PMN K822698 LIFESCAN, INC.	GLUCOSCAN CONTROLS	1982-09-30
PMN K822697 LIFESCAN, INC.	GLUCOSCAN TEST STRIPS	1982-09-30
PMN K810993 LIFESCAN, INC.	GLUCOSCAN TEST STRIPS	1981-04-29
PMN K810665 LIFESCAN, INC.	GILUCOCHEK REFLECTANCE METER	1981-04-17

Related Finance Registrations

NCAGE Code	9X702	LIFESCAN INC
NCAGE Code	9W713	LIFESCAN INC
NCAGE Code	63873	LIFESCAN, INC.
CAGE Code	63873	LIFESCAN, INC.
CAGE Code	9X702	LIFESCAN INC
CAGE Code	9W713	LIFESCAN INC
S.A.M. Registration	63873 [153409313]	LIFESCAN, INC.
SEC	0000744753	LIFESCAN INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018062711688	Felixstowe ,United Kingdom -> Charleston, South Carolina	DIABETES TEST STRIPS HS CODE: 300510	33 PLT
2018061524423	Felixstowe ,United Kingdom -> Charleston, South Carolina	DIABETES TEST STRIPS HS CODE: 300510	33 PLT
2018061149671	Felixstowe ,United Kingdom -> Charleston, South Carolina	DIABETES TEST STRIPS HS CODE: 300510	31 PLT
2018060645397	Felixstowe ,United Kingdom -> Charleston, South Carolina	DIABETES TEST STRIPS HS CODE: 300510	33 PLT
2018060459974	Felixstowe ,United Kingdom -> Charleston, South Carolina	DIABETES TEST STRIPS HS CODE: 300510	33 PLT