Spectrolyse Pai-1, Model 101201

• • Terminated Z-0463-2013 FDA Class II ·initiated 24 Oct 2012

  Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring more frequent sample dilutions.

• • Terminated Z-2431-2012 FDA Class II ·initiated 28 Aug 2012

  SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.

510(k) Number

K063323 ↗

FDA Product Code

GGP

Device Class

Class II

Regulation

21 CFR Part 864.7290

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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