Protime Microcoagulation System

• • Terminated Z-0547-2008 FDA Unclassified (pre-2012) ·initiated 19 Nov 2007

  An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages at the point of routine Quality control checks for the Protime Microcoagulation System.

510(k) Number

K961835 ↗

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. →