Jr. Microcoagulation System

• • Terminated Z-1720-2016 FDA Class II ·initiated 22 Apr 2016

  Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.

• • Terminated Z-2088-2014 FDA Class II ·initiated 20 Jun 2014

  Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.

510(k) Number

K940401 ↗

FDA Product Code

JPA

Device Class

Class II

Regulation

21 CFR Part 864.5425

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. →