Cholestech Lipid Monitoring System, Glucose Test

• • Terminated Z-2402-2011 FDA Unclassified (pre-2012) ·initiated 18 Feb 2011

  The recall was initiated due to an issue related to an error in the encoding of calibration coefficients in the sample cassette that cause the Cholestech LDX analyzer to report glucose values as >500 mg/dL regardless of the true value of the specimen.

510(k) Number

K904082 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Cholestech Lipid Monitoring System, Total Choleste

  Class I

  FDA 510(k) K922612 Active Cleared 24 Jun 1992

• Total Cholesterol and Hdl Cholesterol Panel

  Class I

  FDA 510(k) K946063 Active Cleared 22 Feb 1995

• Total Cholesterol, Hdl Cholesterol and Glucose Panel

  Class I

  FDA 510(k) K946066 Active Cleared 22 Feb 1995

• Cholestech Lipid Monitor Syst, Triglycerides Test

  Class I

  FDA 510(k) K914033 Active Cleared 27 Sep 1991

• Cholestech Lipid Monit Syst, Total Chol/Trig Panel

  Class I

  FDA 510(k) K914469 Active Cleared 30 Oct 1991

• Cholestech L.D.X. Level 1 Control

  Class I

  FDA 510(k) K904784 Active Cleared 18 Dec 1990

See all devices from Cholestech Corp. →