Ecolyzer #200/COHB Analyzer Sys

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

510(k) Number

K832655 ↗

FDA Product Code

CCJ

Device Class

Class II

Regulation

21 CFR Part 868.1430

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →

• What is the Ecolyzer #200/Cohb Analyzer Sys used for?

  The Ecolyzer #200/Cohb Analyzer Sys is used to measure carbon monoxide in the gaseous phase, specifically in the medical specialty of Anesthesiology.

• What is the regulatory classification of the Ecolyzer #200/Cohb Analyzer Sys?

  The device is classified under the regulation number 868.1430 and is a class 2 device.

• What is the product code for the Ecolyzer #200/Cohb Analyzer Sys?

  The product code for the Ecolyzer #200/Cohb Analyzer Sys is CCJ.

• Is the Ecolyzer #200/Cohb Analyzer Sys cleared by the FDA?

  Yes, the Ecolyzer #200/Cohb Analyzer Sys has been cleared with the FDA 510K number K832655, indicating that it is substantially equivalent to a predicate device.