Stratus Cs Acute Care D-Dimer Testpak, Dilpak, Calpak

• • Terminated Z-2283-2012 FDA Class III ·initiated 7 Jun 2012

  Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058002 and 501318002 may exhibit SLOPE or CALCV error messages (instrument errors), which indicate calibration failures.

510(k) Number

K063356 ↗

FDA Product Code

DAP

Device Class

Class II

Regulation

21 CFR Part 864.7320

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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  Class I

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• Dade Tru-Liquid Cardiac Control

  Class I

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• 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

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  Class II

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  Class I

  FDA 510(k) K010871 Active Cleared 9 Jul 2001

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