Flow-Count Coulter Fluorospheres

• • Terminated Z-0525-2008 FDA Unclassified (pre-2012) ·initiated 21 May 2007

  Sporadic absolute count recovery failures with assayed control cell products when using Lot Number 754801F of the Flow-Count Fluorospheres. Additionally, this lot has experienced secondary fluorescent populations containing more than 20% of the total population, as stated in the Evidence of Deterioration section of the Package Insert.

510(k) Number

K954688 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Coulter Albumin Reagent

  Class II

  FDA 510(k) K901268 Active Cleared 30 May 1990

• Coulter Ck (Creatine Kinase) Reagent

  Class II

  FDA 510(k) K901267 Active Cleared 23 May 1990

• Coulter Hdl - Cholesterol Reagent

  Class I

  FDA 510(k) K902174 Active Cleared 31 Jul 1990

• Coulter Total Bilirubin Reagent

  Class II

  FDA 510(k) K901266 Active Cleared 25 Apr 1990

• Coulter Linearity Control

  Class II

  FDA 510(k) K955334 Active Cleared 8 Feb 1996

• Immuno-Trol Control Cells

  Class II

  FDA 510(k) K984216 Active Cleared 16 Mar 1999

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