Ana Hep-2 Fluoro-Kit

• • Terminated Z-0807-05 FDA Unclassified (pre-2012) ·initiated 24 Sep 2004

  A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (including values changed to unacceptable values) after the initial curve has been generated, if the 'refresh button' has not been pressed. The graph may appear valid; however erroneous results may occur.

• • Terminated Z-0676-05 FDA Unclassified (pre-2012) ·initiated 30 Jun 2004

  The program for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrectly programmed as 1:120 instead of 1:160.

510(k) Number

K822397 ↗

FDA Product Code

DHN

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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