Advanced D-Dimer Assay

• • Terminated Z-0172-06 FDA Unclassified (pre-2012) ·initiated 29 Jul 2005

  Reports of false negative results on Sysmex Coagulation System.

• • Terminated Z-0538-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004

  decrease in product stability after reconstitution and reduced stability on board certain instrument systems

510(k) Number

K041438 ↗

FDA Product Code

DAP

Device Class

Class II

Regulation

21 CFR Part 864.7320

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Apolipoprotein Control Serum Chd, Model Ouph

  Class I

  FDA 510(k) K993310 Active Cleared 30 Nov 1999

• Dade Tru-Liquid Cardiac Control

  Class I

  FDA 510(k) K981622 Active Cleared 8 Jun 1998

• Stratus Cs Acute Care Troponin I Testpak, Model Cctni

  Class II

  FDA 510(k) K033487 Active Cleared 24 Dec 2003

• Behring Coagulation System, Model BCS

  Class II

  FDA 510(k) K002080 Active Cleared 16 Nov 2000

• Modification to N Protein Standard Sl

  Class II

  FDA 510(k) K012470 Active Cleared 28 Sep 2001

• Tgl Flex Reagent Cartridge

  Class I

  FDA 510(k) K010871 Active Cleared 9 Jul 2001

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