Quantafluor Fluorescent Test Reagents

• • Terminated Z-3051-2011 FDA Unclassified (pre-2012) ·initiated 30 Jun 2010

  KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.

• • Terminated Z-2429-2008 FDA Unclassified (pre-2012) ·initiated 29 Jul 2008

  The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.

510(k) Number

K813592 ↗

FDA Product Code

DHN

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Quantitope 125-I Gentamicin Ria Kit

  Class II

  FDA 510(k) K780323 Active Cleared 17 Mar 1978

• Kallestad Antisera to Tobramycin

  Class II

  FDA 510(k) K812415 Active Cleared 9 Sep 1981

• Ria Kit, Quantitope Cortisol

  Class II

  FDA 510(k) K781903 Active Cleared 26 Jan 1979

• Mark 500 System

  Not classified

  FDA 510(k) K812416 Active Cleared 8 Apr 1982

• Quantimetric Plus C4 Reagent Kit

  Class II

  FDA 510(k) K855012 Active Cleared 26 Feb 1986

• Quanticoat Neonatal 125 T4 Radioimmuno

  Class II

  FDA 510(k) K812611 Active Cleared 2 Oct 1981

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