Mmb Calibrator

• • Terminated Z-1925-2013 FDA Class II ·initiated 5 Jun 2013

  Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU). The frequency of this occurrence is low but if it occurs, gel-like clumps may be observed.

510(k) Number

K970336 ↗

FDA Product Code

JIT

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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