Skip to content

FreeStyle Lite Blood Glucose Monitoring System

by Abbott Laboratories

510(k) K150332

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK150332 Date5 Jun 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The FreeStyle Lite Blood Glucose Monitoring System is a device intended for measuring blood glucose levels. It is designed for use by individuals with diabetes to monitor their glucose levels as part of diabetes management.

The system is supplied for prescription use and is authorized under FDA 510(k) clearance (K150332). It is intended for use in home or clinical settings by patients or healthcare professionals, and its specifications include the exact model name and manufacturer details as provided in the authorization data.

Other devices from Abbott Laboratories

See all devices from Abbott Laboratories →

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the FreeStyle Lite Blood Glucose Monitoring System used for?

    The FreeStyle Lite Blood Glucose Monitoring System is intended for measuring blood glucose levels. It is designed for use by individuals with diabetes to monitor their glucose levels as part of diabetes management, supporting self-testing or professional use in home or clinical environments.

  • How is the FreeStyle Lite Blood Glucose Monitoring System supplied and who can use it?

    The system is supplied for prescription use and is intended for use by patients with diabetes or healthcare professionals. It can be used in home or clinical settings, allowing flexibility for individuals managing their condition or clinicians assisting with glucose monitoring.

  • Is the FreeStyle Lite Blood Glucose Monitoring System sterile or single-use?

    The device data does not specify sterility or single-use status for the FreeStyle Lite Blood Glucose Monitoring System. As a blood glucose monitoring system, it typically includes a reusable meter and disposable test strips, but reuse or sterility details are not provided in the authorization information.

  • What regulatory pathway was used for the FreeStyle Lite Blood Glucose Monitoring System?

    The FreeStyle Lite Blood Glucose Monitoring System was authorized under FDA 510(k) clearance, specifically under submission K150332. The decision was made on June 5, 2015, and the device was found substantially equivalent to a predicate device, with a special clearance type and product code NBW.