Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin I

• • Terminated Z-1274-2012 FDA Not yet classified ·initiated 25 Jan 2012

  Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference applies to all IMMULITE platforms.

510(k) Number

K034055 ↗

FDA Product Code

JHX

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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