Bd Facscount CD4 Reagents with Model 339010

• • 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).

• • 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

K081213 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Bd Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2), Model 338962

  Class II

  FDA 510(k) K062087 Active Cleared 14 Sep 2006

• BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)

  Class II

  FDA 510(k) K141468 Active Cleared 27 Feb 2015

• Steller CD61 Assay for Use on the Imagn 2000 Microvolume Fluorimeter

  Class II

  FDA 510(k) K000611 Active Cleared 18 May 2000

• Bd Facscanto with Bd Facsanto Software

  Class II

  FDA 510(k) K041074 Active Cleared 17 Sep 2004

• Bd Tritest CD3/CD4/CD45, Model 340383

  Class II

  FDA 510(k) K071143 Active Cleared 6 Jun 2007

• BD Tritest CD3/CD4/CD45 With BD Trucount Absolute Count Tubes, Model 340402

  Class II

  FDA 510(k) K071141 Active Cleared 6 Jun 2007

See all devices from Bd Biosciences →