Dade Indirect Imt System with TCO2 Electrode

• • Terminated Z-1398-2015 FDA Class II ·initiated 24 Feb 2015

  A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check correction if the positive bias is greater than 1% and less than 5%. The dilution check correction would be detected by QC; however, if not detected by QC, the calibration curve would be decreased and cause elevated sodium, potassium and chloride patient results.

510(k) Number

K970330 ↗

FDA Product Code

CEM

Device Class

Class II

Regulation

21 CFR Part 862.1600

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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