Creatine Kinase Mb Determination (UV)

• • Terminated Z-2649-2017 FDA Class III ·initiated 22 Nov 2010

  Incorrect control range in product labeling

510(k) Number

K942958 ↗

FDA Product Code

JHW

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Glucose Enzyme - Color Reagent Set

  Class II

  FDA 510(k) K871650 Active Cleared 12 May 1987

• Colorimetric Bun Reagent Kit

  Class II

  FDA 510(k) K871651 Active Cleared 12 May 1987

• Ultra-Violet Glucose Reagent Kit

  Class II

  FDA 510(k) K871456 Active Cleared 29 Apr 1987

• Albumin Reagent Set

  Class II

  FDA 510(k) K905776 Active Cleared 26 Feb 1991

• Cholesterol Determination

  Class I

  FDA 510(k) K871260 Active Cleared 13 Apr 1987

• Kinetic Alkaline Phosphatase Determination

  Class II

  FDA 510(k) K905650 Active Cleared 13 Feb 1991

See all devices from Biochemical Trade, Inc. →