Biotrack Protime Test Prothrombin Time Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K860721 ↗

FDA Product Code

GJS

Device Class

Class II

Regulation

21 CFR Part 864.7750

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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  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 Hemoglobin Test Cartridge

  Class II

  FDA 510(k) K895101 Active Cleared 10 Oct 1989

• Biotrack Alt Test Cartridge

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• Biotrack Protime Controls (Biotrack Protime Test)

  Class II

  FDA 510(k) K860719 Active Cleared 23 May 1986

• Biotrack Therapeutic Drug Monitoring Qual. Control

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  FDA 510(k) K920525 Active Cleared 5 Aug 1992

See all devices from Biotrack, Inc. →