Biotrack Hemoglobin Test Cartridge

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K895101 ↗

FDA Product Code

KHG

Device Class

Class II

Regulation

21 CFR Part 864.7500

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Biotrack Phenytoin Test Cartridge

  Class II

  FDA 510(k) K915755 Active Cleared 23 Jul 1992

• Biotrack Theophylline Quality Controls

  Class I

  FDA 510(k) K903924 Active Cleared 17 Sep 1990

• Biotrack Alt Test Cartridge

  Class I

  FDA 510(k) K895128 Active Cleared 6 Oct 1989

• Biotrack Protime Controls (Biotrack Protime Test)

  Class II

  FDA 510(k) K860719 Active Cleared 23 May 1986

• Biotrack Therapeutic Drug Monitoring Qual. Control

  Class II

  FDA 510(k) K920525 Active Cleared 5 Aug 1992

• Biotrack Protime Test Prothrombin Time Test

  Class II

  FDA 510(k) K860721 Active Cleared 23 May 1986

See all devices from Biotrack, Inc. →