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Precision Link Diabetes Data Management System

by Abbott Laboratories 510(k)

Active United States

510(k) K040628

Overview

The Precision Link Diabetes Data Management System is a data management tool intended to collect and report information to assist with diabetes management. It is classified as a System, Test, Blood Glucose, Over The Counter device under product code NBW and Class II with Special Controls.

The system was submitted by Abbott Laboratories and received FDA 510(k) clearance (K040628) on March 25, 2004, following a determination of substantial equivalence. It is manufactured at 4-A Crosby Dr., Bedford, MA 01730, and is intended for use in diabetes data management as specified in the device documentation.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK040628 Date25 Mar 2004ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
NBW
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Precision Link Diabetes Data Management System used for?

    The Precision Link Diabetes Data Management System is intended to collect and report information to assist with diabetes management. It functions as a data management tool for blood glucose data, helping users and clinicians track and analyze glucose trends over time to support treatment decisions.

  • How is the Precision Link Diabetes Data Management System supplied and is it reusable?

    The system is supplied as a data management tool, likely including software and hardware components for data collection and reporting. Based on its classification as an Over The Counter device and intended use for ongoing diabetes management, it is designed for repeated use rather than single-use, though specific reuse protocols should be followed per manufacturer instructions.

  • What regulatory pathway was used for the Precision Link Diabetes Data Management System?

    The Precision Link Diabetes Data Management System received FDA 510(k) clearance (K040628) on March 25, 2004, following a determination of substantial equivalence to a legally marketed predicate device. It is classified as a Class II device under product code NBW with Special Controls.