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Precision Xceed Diabetes Monitoring System

by Abbott Laboratories

510(k) K033845

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK033845 Date8 Jan 2004ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0112-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007

    Damage could lead to no display. Meters manufactured after January 31, 2007 could exhibit meter display damage if dropped on a hard surface. These meters could exhibit unreadable lot number fields and date/time fields, in addition to complete blanking of the numerical reading portion of the display.

    • Terminated Z-0856-2007 FDA Unclassified (pre-2012) initiated 5 Mar 2007

    The front button covers may detach from the meter.

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  • Withdrawn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 Precision Xceed Diabetes Monitoring System is a blood glucose and beta-ketone monitoring system. It is designed for point-of-care testing to measure glucose and ketone levels in blood samples.

The system is supplied as a reusable monitoring device with docking station capability for automatic data transfer. It is intended for use in clinical settings and has received FDA 510(k) clearance under product code NBW, with submission K033845.

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