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

• • 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-1530-2008 FDA Unclassified (pre-2012) ·initiated 21 Dec 2007

  Values might not update in statistics views after certain functions are performed in a worksheet.

• • Terminated Z-1525-2008 FDA Unclassified (pre-2012) ·initiated 5 Apr 2007

  When data file containing one or no fluoresence parameters is exported, the software will automatically apply compensation to this file and all subsequently exported files.

510(k) Number

K062087 ↗

FDA Product Code

GKZ

Models / Variants

Bd Facscanto Ii Flow Cytometer, Model 338960

(5-3), Model 339473

(4-2-2), Model 338962

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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

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• Calibrite Percp-CY5.5 Beads and Facscomp Software

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