Protime Microcoagulation System

• • Terminated Z-0548-2008 FDA Unclassified (pre-2012) ·initiated 19 Nov 2007 ·on shared 510(k) K951072

  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.

• • Terminated Z-0470-2007 FDA Unclassified (pre-2012) ·initiated 6 Dec 2006 ·on shared 510(k) K951072

  Incorrect Test Results-ProTime ITC''s Microcoagulation System: Professional Instrument may report incorrect test results when more than 50 tests are in the memory and the technician uses the AUTO Send or PRINT RESULTS feature.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K951072 ↗

FDA Product Code

GKP

Device Class

Class II

Regulation

21 CFR Part 864.5400

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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  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

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  FDA 510(k) K972831 Active Cleared 20 Nov 1997

• Tenderfoot

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  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

• Hemochron Direct Draw Aptt/Fac VI Vacu-Aptt

  Class II

  FDA 510(k) K924638 Active Cleared 14 Jan 1993

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