Stratus Cs Acute Care Nt-Probnp Testpak, Model Cpbnpm

• • Terminated Z-0610-2016 FDA Class II ·initiated 11 Nov 2015

  Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

• • Terminated Z-1516-2012 FDA Not yet classified ·initiated 5 Apr 2012

  Firm has confirmed a low frequency of calibration failures due to slope errors that are not resolved with routine maintenance with the specific SCS Pro-BNP lots listed. This issue only causes the slope error failures but does not affect patient results when the calibration is within specifications.

510(k) Number

K071834 ↗

FDA Product Code

NBC

Device Class

Class II

Regulation

21 CFR Part 862.1117

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Stratus Cs Acute Care Troponin I Testpak, Model Cctni

  Class II

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• Behring Coagulation System, Model BCS

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  Class II

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  Class I

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