Calibration Standard-Hemoglobin

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K831814 ↗

FDA Product Code

KRZ

Device Class

Class II

Regulation

21 CFR Part 864.8165

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

• Co-Oximeter Control

  Class II

  FDA 510(k) K831813 Active Cleared 28 Jul 1983

• 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

See all devices from United Diagnostics, Inc. →