Actin Fsl Activated Ptt Reagent

• • Terminated Z-1073-2013 FDA Class II ·initiated 11 Mar 2013

  Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.

• • Terminated Z-1043-2012 FDA Unclassified (pre-2012) ·initiated 19 Dec 2011

  The listed lots of Dade(R) Actin(R) FSL Reagent show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.

510(k) Number

K863594 ↗

FDA Product Code

GGW

Device Class

Class II

Regulation

21 CFR Part 864.7925

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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