Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set

• • Terminated Z-2090-2015 FDA Class III ·initiated 15 Jun 2015

  Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50).

510(k) Number

K973483 ↗

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 →