Hemochron Jr. Microcoagulation Low Range Act

• • Ongoing Z-0880-2026 FDA Class II ·initiated 5 Nov 2025

  Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.

• • Terminated Z-1732-2009 FDA Unclassified (pre-2012) ·initiated 5 May 2009

  One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria.

• • Terminated Z-1381-05 FDA Unclassified (pre-2012) ·initiated 27 Apr 2005

  Validation had been initiated for a molded component of the finished device but not completed. Also, the device did not meet mean clotting time using Normal Donor Blood as media.

510(k) Number

K960749 ↗

FDA Product Code

JBP

Device Class

Class II

Regulation

21 CFR Part 864.7140

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Hemochron(R) Kact

  Class II

  FDA 510(k) K913861 Active Cleared 18 Oct 1991

• Hemochron Jr Generation II, Hemochron Jr Signature

  Class II

  FDA 510(k) K974799 Active Cleared 7 Jul 1998

• Hemochron Citrate Aptt

  Class II

  FDA 510(k) K972831 Active Cleared 20 Nov 1997

• Protime Microcoagulation System

  Class II

  FDA 510(k) K951072 Active Cleared 27 Oct 1995

• Tenderfoot

  Class II

  FDA 510(k) K883968 Active Cleared 1 Dec 1988

• Prothrombin Time (Pt) by Hemochron, Modification

  Class II

  FDA 510(k) K911995 Active Cleared 17 Jul 1991

See all devices from International Technidyne Corp. →