Olympus Creatinine Reagent

• • Terminated Z-0958-2013 FDA Class II ·initiated 28 Dec 2012

  Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance.

510(k) Number

K934361 ↗

FDA Product Code

CGX

Device Class

Class II

Regulation

21 CFR Part 862.1225

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Olympus Direct Bilirubin Reagent

  Class II

  FDA 510(k) K924963 Active Cleared 30 Nov 1992

• Olympus Chloride Reagent, Modification

  Class II

  FDA 510(k) K934136 Active Cleared 5 Nov 1993

• Resectoscope Sheath

  Class II

  FDA 510(k) K931994 Active Cleared 17 Feb 1994

• Olympus Measuring Devices

  Class II

  FDA 510(k) K933717 Active Cleared 2 Nov 1993

• Sterile Disposable Cytology Brush

  Not classified

  FDA 510(k) K802187 Active Cleared 10 Sep 1980

• Olympus Infant Resectoscope and Accessories

  Class II

  FDA 510(k) K904940 Active Cleared 13 Jan 1992

See all devices from Olympus Corp. →