Protime Microcoagulation System / Protime 3 Cuvette

• • Terminated Z-2198-2013 FDA Class II ·initiated 16 Jul 2013

  The products may have been stored at temperatures outside their required storage conditions.

• • Terminated Z-0837-2013 FDA Class II ·initiated 28 Sep 2012

  Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results.

• • Terminated Z-0546-2008 FDA Unclassified (pre-2012) ·initiated 19 Nov 2007

  An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages.

510(k) Number

K010599 ↗

FDA Product Code

GJS

Device Class

Class II

Regulation

21 CFR Part 864.7750

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. →