Acticlot, Model 824

• • Terminated Z-0779-2007 FDA Unclassified (pre-2012) ·initiated 28 Feb 2007 ·on shared 510(k) K052124

  Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas

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

510(k) Number

K052124 ↗

FDA Product Code

GJS

Device Class

Class II

Regulation

21 CFR Part 864.7750

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Dimertest

  Class II

  FDA 510(k) K080069 Active Cleared 13 Feb 2008

• Actichrome Heparin (Anti-Fxa), Model 832

  Class II

  FDA 510(k) K013318 Active Cleared 8 Mar 2002

• Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control Plasma

  Class II

  FDA 510(k) K935254 Active Cleared 19 Sep 1994

• Spectrolyse Pai-1, Model 101201

  Class II

  FDA 510(k) K063323 Active Cleared 15 Aug 2007

• Imubind Tpa Elisa, Model 860

  Class II

  FDA 510(k) K013492 Active Cleared 13 Mar 2002

• Dv Test and Dvv Confirm

  Class I

  FDA 510(k) K940490 Active Cleared 5 Apr 1995

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