Bd Tritest CD3/CD4/CD45, Model 340383

• • Terminated Z-2378-2016 FDA Class III ·initiated 18 Jul 2016

  Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer.

510(k) Number

K071143 ↗

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 With BD Trucount Absolute Count Tubes, Model 340402

  Class II

  FDA 510(k) K071141 Active Cleared 6 Jun 2007

• Calibrite Percp-CY5.5 Beads and Facscomp Software

  Class II

  FDA 510(k) K000897 Active Cleared 5 May 2000

See all devices from Bd Biosciences →