Co-Oximeter Control

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K831813 ↗

FDA Product Code

KHG

Device Class

Class II

Regulation

21 CFR Part 864.7500

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Stat-Trak Liquid Electrolyte Control

  Class I

  FDA 510(k) K831389 Active Cleared 10 Aug 1983

• Stat-Trak Plus Liquid Chemistry Controls 1, 2 & 3

  Class I

  FDA 510(k) K843986 Active Cleared 27 Nov 1984

• Gas Trak Plus

  Class I

  FDA 510(k) K884977 Active Cleared 27 Jan 1989

• Gas-Trak

  Class I

  FDA 510(k) K862278 Active Cleared 4 Aug 1986

• Ampuled Flame Photometer Standards

  Class II

  FDA 510(k) K810618 Active Cleared 31 Mar 1981

• Gas Trak Brand Co-Oximeter Controls 1, 2 & 3

  Class I

  FDA 510(k) K844018 Active Cleared 27 Nov 1984

See all devices from United Diagnostics, Inc. →