Cholestech Bun/Creatinine Test System

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K972012 ↗

FDA Product Code

CDN

Device Class

Class II

Regulation

21 CFR Part 862.1770

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. →