LIFESCAN SCOTLAND LTD

FDA Device Registration & Listing · INVERNESS Highland, GB · Registration 3001058982

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3001058982
FEI Number
3001058982
Entity Name
LIFESCAN SCOTLAND LTD
City/State/Country
INVERNESS Highland, GB
Establishment Address
BEECHWOOD PARK NORTH, INVERNESS Highland IV2 3ED, GB
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Lifescan Scotland Ltd. (Owner Number: 9026104)
Owner / Operator Contact Address
Beechwood Park North, Inverness, GB-HLD IV2 3ED, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

OneTouch Verio Control Solution OneTouch Verio Test Strips OneTouch Verio IQ Blood Glucose Meter OneTouch Verio IQ Blood Glucose Monitoring System OneTouch Select Control Solutions OneTouch Ultra Control Solutions One Touch Ultra Mini Blood Glucose Monitoring System OneTouch Ultra Blue Test Strips OneTouch Ultra Mini Meter OneTouch Ultra Blue Test Strips OneTouch Select Meter OneTouch Select Blood Glucose Monitoring System OneTouch Select Test Strip OneTouch Verio Blood Glucose Monitoring System OneTouch Verio Meter OneTouch Verio Control Solution OneTouch Verio Test Strips OneTouch Verio Reflect Blood Glucose Monitoring System OneTouch ultra Blue Test Strips OneTouch Ping Meter Remote OneTouch Ultra Plus Flex Blood Glucose Monitoring System OneTouch Ultra Plus Control Solution OneTouch Ultra Plus Test Strips OneTouch Ultra Plus Flex Meter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2012-06-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-06-08
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-06-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2007-12-10
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2007-12-10
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2007-12-10
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2007-12-10
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2007-12-10
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2017-04-27
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2017-04-27
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2021-04-06
LZG Pump, Infusion, Insulin General Hospital Class 2 880.5725 2009-12-16
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2009-12-16
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2017-04-27
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2017-04-27

Official Correspondent

Polly Middleton

US Agent Details

Amber Wingler Business: LIFESCAN US LLC. Email: awingler@lifescan.com Phone: (484) 3207594

Related Public Records

Same Entity

Lifescan Scotland Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K973662 Boehringer Mannheim Corp. ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS 1997-12-15
K150396 Apex BioTechnology Corp. Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips 2015-10-14
K150833 Andon Health Co, Ltd. iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System 2015-12-04
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2009 Lifescan Inc 2
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06 Abbott Laboratories Medisense Products 2
FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06 Abbott Laboratories Medisense Products 2
Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06 Abbott Laboratories Medisense Products 2
Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001058982. Last updated year: 2026. Please use registration number 3001058982 when referencing this establishment in official correspondence.
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