Ascensia Diabetes Care US Inc.

FDA Device Registration & Listing · Valhalla, NY, US · Registration 1810909

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
1810909
FEI Number
1810909
Entity Name
Ascensia Diabetes Care US Inc.
City/State/Country
Valhalla, NY, US
Establishment Address
100 Summit Lake Drive, Valhalla, NY 10595, 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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
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
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 2017-01-20
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2017-01-20
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
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2023-04-12
OZO Automated Insulin Dosing , Threshold Suspend Unknown Class 3 N/A 2016-08-11
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 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
OZO Automated Insulin Dosing , Threshold Suspend Unknown Class 3 N/A 2020-04-03
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2024-05-13
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
OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown Class 3 N/A 2017-12-14
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
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2025-03-12
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
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-11-15
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2017-01-20
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2017-01-20
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2021-09-13
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2021-09-13
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2022-01-31
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2016-01-21
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 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
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-04-03

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
3011121740 Ascensia Diabetes Care US Inc. Parsippany, NJ, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K781173 Instrumentation Laboratory CO COMPUTER INTERFACE IL 814 1978-09-14
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-04 Misys Healthcare Systems 1
Calculator/Data Processing Module for Clinical Use
Z-0026-2025 Becton Dickinson & Co. 1
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
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

Similar Registrations

Registration Number Establishment Name Location
3004032053 Abbott S.r.l. Milan Lombardy, IT
3013922172 INDIGO BIOAUTOMATION, INC. Carmel, IN, US
3012436569 NATIONAL TECHNOLOGY FOR SOFTWARE Cairo Al Qahirah, EG
3015426626 Aclarion, Inc. Broomfield, CO, US
3030413550 LIFE DATA LAB, LLC New York, NY, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1810909. Last updated year: 2026. Please use registration number 1810909 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.