Ultra+ Blood Glucose Test Strip

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

510(k) Number

K915770 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Diascan Blood Glucose Monitoring Test Strip

  Class II

  FDA 510(k) K915772 Active Cleared 14 Apr 1992

• Trueresult Blood Glucose System E4H01-81 Open recall

  Class II

  FDA 510(k) K080641 Active Cleared 19 Aug 2008

• TRUE2GO Blood Glucose System, Model F4H01-81 Open recall

  Class II

  FDA 510(k) K080710 Active Cleared 13 Aug 2008

• Prestige Lx Blood Glucose Test System

  Class II

  FDA 510(k) K992988 Active Cleared 24 Sep 1999

• Modification to Truetrack Smart System Blood Glucose Meter, Test Strips and Glucose Control

  Class II

  FDA 510(k) K040670 Active Cleared 25 Mar 2004

• Truebalance Blood Glucose System Open recall

  Class II

  FDA 510(k) K090495 Active Cleared 27 Mar 2009

See all devices from Home Diagnostics, Inc. →

• What is the Ultra+ Blood Glucose Test Strip used for?

  The Ultra+ Blood Glucose Test Strip is used to measure glucose quantitatively in blood and other body fluids for the diagnosis and treatment of carbohydrate metabolism disorders.

• Is the Ultra+ Blood Glucose Test Strip supplied sterile?

  The device data does not specify if the Ultra+ Blood Glucose Test Strip is supplied sterile, but it is intended for single-use.

• What is the regulatory classification of the Ultra+ Blood Glucose Test Strip?

  The Ultra+ Blood Glucose Test Strip is classified as a class 2 device, regulated under product code CGA, with a regulation number of 862.1345.