Bayer Advia Centaur Her-2/Neu Assay

• • Terminated Z-0115-2021 FDA Class II ·initiated 25 Aug 2020

  Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative results.

510(k) Number

K024017 ↗

FDA Product Code

NCW

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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