Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011121740

FEI Number

3010700165

Entity Name

Ascensia Diabetes Care US Inc.

City/State/Country

Parsippany, NJ, US

Establishment Address

5 Wood Hollow Road, Parsippany, NJ 07054, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Ascensia Diabetes Care Holdings AG (Owner Number: 10050965)

Owner / Operator Contact Address

5 WOOD HOLLOW RD, Parsippany, NJ 07054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241810

PMA Number

N/A

All Registered Proprietary Names

Contour Next EZ Blood Glucose Meter Contour Next Control Solution Contour Next Blood Glucose Test Strips Contour Next Link Wireless Blood Glucose Meter Contour Next Blood Glucose Test Strips Contour Next Control Solution MICROLET NEXT lancing device, MICROLET Lancet Contour Next Link Wireless Blood Glucose Meter Contour Next Blood Glucose Test Strips Contour Next Blood Glucose Test Strips Contour Next Blood Glucose Monitoring System Contour Next Blood Glucose Meter Contour Next Control Solution Contour Next ONE Blood Glucose Monitoring System Glucofacts Deluxe Diabetes Management Software CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System Contour Next Blood Glucose Test Strips Contour Next Link 2.4 Wireless Blood Glucose Meter Ketostix, Keto-Diastix Contour Control Solution Contour Next Control Solution CONTOUR NEXT ONE CONTOUR PLUS CONTOUR NEXT CONTOUR NEXT LINK CONTOUR NEXT EZ CONTOUR PLUS ONE CONTOUR PLUS LINK Contour Next Blood Glucose Meter Contour Next Control Solutions Contour Next EZ Blood Glucose Meter Contour Next USB Blood Glucose Monitoring System Contour Next Blood Glucose Monitoring System Contour Next EZ Blood Glucose Monitoring System Contour Next USB Blood Glucose Meter Contour Next LINK Wireless Blood Glucose Meter Contour Next LINK Wireless Blood Glucose Monitoring System Contour Next ONE Blood Glucose Monitoring System Contour Next Blood Glucose Test Strips Contour Next ONE Blood Glucose Meter Glucofacts Deluxe Diabetes Management System Contour Next Link 2.4 Wireless Blood Glucose Monitoring System Contour Next Blood Glucose Test Strips Contour Next Link 2.4 Wireless Blood Glucose Meter CONTOUR® PLUS BLUE Blood Glucose Monitoring System CONTOUR NEXT LINK 2.4 CONTOUR PLUS LINK 2.4 Contour® next GEN Blood Glucose Monitoring System Contour Next EZ Blood Glucose Monitoring System Contour Next EZ Blood Glucose Meter Contour Next Blood Glucose Test Strips Contour Contour TS MICROLET®NEXT Lancets

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	2016-01-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-01-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-01-21
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-01-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-01-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-01-21
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-11-18
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-01-21
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-01-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-01-21
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-01-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-01-21
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-11-22
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-11-22
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-01-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2025-03-12
OZP	Automated Insulin Dosing Device System, Single Hormonal Control	Unknown	Class 3	N/A	2017-12-14
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2016-01-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2018-10-24
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-10-24
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2018-10-24
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-01-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2020-04-03
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2019-11-15
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2016-01-21
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-01-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-01-21
OZO	Automated Insulin Dosing , Threshold Suspend	Unknown	Class 3	N/A	2016-08-11
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2024-05-13
OZP	Automated Insulin Dosing Device System, Single Hormonal Control	Unknown	Class 3	N/A	2020-04-03
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2022-01-31
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-01-21
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-01-21
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-01-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-01-21
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2026-03-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ascensia Diabetes Care Holdings AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038419886	Ascensia Diabetes Care Poland Sp. z o.o.	Warszawa Mazowieckie, PL
3012118659	ASCENSIA DIABETES CARE HOLDINGS AG	Basel Basel-Stadt, CH
1810909	Ascensia Diabetes Care US Inc.	Valhalla, NY, US

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
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
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

Similar Registrations

Registration Number	Establishment Name	Location
3014353121	VIDAN DIAGNOSTICS, LLC	San Antonio, TX, US
3012118659	ASCENSIA DIABETES CARE HOLDINGS AG	Basel Basel-Stadt, CH
1810909	Ascensia Diabetes Care US Inc.	Valhalla, NY, US
2954323	ABBOTT DIABETES CARE INC.	ALAMEDA, CA, US
3003741676	ANDON HEALTH CO., LTD	TIANJIN, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011121740. Last updated year: 2026. Please use registration number 3011121740 when referencing this establishment in official correspondence.