Fascount Systme

• • Terminated Z-1007-2010 FDA Unclassified (pre-2012) ·initiated 29 Jan 2009

  The product is mislabeled, in that, zero/low controls were mislabeled as medium/high, and the medium/high controls were labeled zero/low.

510(k) Number

K933486 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Tritest CD3 Fitc/CD19 Pe/CD45 Percp Reagent with Trucount Absolute Count Tubes

  Class II

  FDA 510(k) K970742 Active Cleared 22 Oct 1997

• Bd Facs 7-Color Setup Beads Open recall

  Class II

  FDA 510(k) K040026 Active Cleared 10 Sep 2004

• Trucount Absolute Count Tubes/Counting Control Beads

  Class II

  FDA 510(k) K970836 Active Cleared 26 Aug 1997

• Bd Facscanto System

  Class II

  FDA 510(k) K040725 Active Cleared 10 Sep 2004

• Multitest CD3/CD8/CD45/CD4

  Class II

  FDA 510(k) K974360 Active Cleared 11 Mar 1998

• Simultest CD3/Anti-Hla-Dr

  Class II

  FDA 510(k) K924587 Active Cleared 5 Aug 1993

See all devices from Becton Dickinson Immunocytometry Systems →