Colloid Osmometer 4400

• 2 recalls, same reason

  • Terminated Z-1351-2008 FDA Unclassified (pre-2012) ·initiated 26 Dec 2007
  • Terminated Z-1350-2008 FDA Unclassified (pre-2012) ·initiated 26 Dec 2007

  Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.

510(k) Number

K834208 ↗

FDA Product Code

JJM

Device Class

Class I

Regulation

21 CFR Part 862.2730

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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